1. WELCOME TO THE ATLANTA VA MEDICAL CENTER
This reference manual will provide you with the Atlanta VA Medical Center’s policies and step by step procedures for conducting human subjects research.
The Atlanta VA Human Research Protection Program has the infrastructure for conducting research that ensures consistency in quality and performance which is in accordance with federal regulations and institutional policies.
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2. Atlanta VA Medical Center Research webpage location:
Clinical Studies Center forms and policies are located at:

3. Investigator’s Responsibilities
Principal Investigator Definition:
An individual who conducts a research study and under whose immediate direction the investigation occurs. When a team of individuals conducts a study, the responsible leader of the team is the Principal Investigator (PI).
The Atlanta VA Research & Development (R&D) Committee is responsible for ensuring that:
Investigators are qualified to conduct the study.
The PI is trained and knowledgeable about the disease or condition described in the protocol.
The investigator has completed VA required training

4. Investigator’s Responsibilities
Ensure the safety and welfare of study participants.
Comply with VA policies and procedures and federal regulations for conducting human subjects research.
Is solely responsible for the conduct of the study.
Has sufficient, qualified, and trained study staff to conduct the study.
Ensure that all study team members complete research credentialing and training before engaging in research activities.
Document any delegated responsibilities to study staff in the research “Scope of Practice”.
Supervise and oversee all study activities.

5. Investigator’s Responsibilities
Communicate with study members on an ongoing basis about all aspects of the study.
Ensure that study members are knowledgeable about the protocol and follow study activities accurately.
Obtain Emory IRB, VA Sub-Committee on Research Safety, VA Radiation Sub-Committee (if applicable), ISO/PO and R&D Committee approval prior to initiating any study activities. These will be represented in a FINAL letter of approval from the ACOS/R.
Delegate in writing (in protocol or IRB submission) who will be obtaining consent.
Obtain informed consent & HIPAA Authorization from each participant prior to starting any study activities or delegates this responsibility to qualified research staff.
Adhere to the research protocol procedures.
Maintain adequate and accurate documentation for each participant.

6. Investigator’s Responsibilities
Document research encounters in the subject's medical record.
Comply with protocol reporting obligations to the IRB and R&D Committee regarding study changes, annual progress, research-related unanticipated problems involving risks to the subject or other individuals, Reportable Events and conflict of interest.
Keep study regulatory documents organized in a study binder and study records locked in a secured area (secured = behind TWO locks).
Keep all data collected for the research study at the VA (unless offsite authorization has been obtained).
Prepare for internal and external audits as required.
Follow study records retention guidelines.
Be available for Sponsor Site Visits prior to, during and at the end of the study.

7. Research Staff Responsibilities
Research Coordinator Definition:
The person who assists the Principal Investigator (PI) in the conduct of the study and usually handles most of the administrative responsibilities. In addition, acts as a liaison between the PI, sponsor, IRB, and R&D Committee.
The “Research Staff Responsibilities” policy is located at:

8. Research Staff Responsibilities
Complete required research training and credentialing prior to engaging in study activities.
Conduct study in accordance with federal regulations and institutional policies.
Follow the Privacy Rules regarding privacy and use of Protected Health Information (PHI).
Coordinate day-to-day study protocol activities as delegated by the PI.
Assist with IRB and R&D regulatory issues as required.
Ensure the safety and welfare of the study participants.
Perform protocol activities correctly and completely.
If appropriate, provide an in-service to hospital staff impacted by the research study.

9. Research Staff Responsibilities
Recruit and screen potential study participants according to the protocol criteria.
Document all research activities as required by VA policies.
When delegated, obtain informed consent and HIPAA Authorization from each subject prior to starting any study activities.
Promptly report any Reportable Events (REs) and Unanticipated Problems (UPs) to the Investigator, study sponsor, and the IRB.
Accurately collects study data in the Case Report Forms (CRFs) for each participant.
Maintain adequate and accurate source documents for each study participant and records all observations during the study.

10. Research Staff Responsibilities
Maintain an organized filing system for all regulatory documentation and other study records.
Keep accurate records of screened and enrolled subjects.
Maintain ongoing communication with the PI about study activities.
Obtain research education on an ongoing basis. Regularly attend research meetings.
Read all research policies and procedures located on the Atlanta VA research website Stay informed of all policy and procedure changes by checking the website regularly.
Regarding Industry-Sponsored Studies
Keep accurate records of the receipt, dispensing, return of all clinical supplies, and study drug or device accountability.
Communicate study activities to the sponsor as required and be available for the study sponsor monitoring visits to discuss and review study data.

11. Preparing for a Research Study
Attend the sponsor investigator meetings as required.
Identify study population and their availability. Based on this assessment, develop a recruitment plan.
In the event that conflicting research studies are being conducted, the PI should negotiate access to study population with the Investigator involved.
Contact CSC Medical Director for guidance with protocol design and review.
Contact the Human Studies Analyst for assistance with VA forms and overall aspects of the protocol submission process.
Prepare recruitment materials for IRB review and approval.

12. Preparing for a Research Study
Prepare Case Report Forms (CRF) for study data collection.
Start a Study Binder (available at CSC) to keep paper copies of all regulatory documents and prepare any study tools (source documents templates, tracking tools, etc).
Define study reimbursement procedures in advance.
Define and disclose the recruitment plan and how the study data will be secured, used, disclosed and/or transferred in the protocol.
Obtain access to the VA research secured server (authorized by the Director of Research Operations) to save all electronic study data.
In order to use the eIRB system, staff must obtain an account by following instructions at: .

13. Preparing for a Research Study
Obtain the final research protocol from the study sponsor for review and feasibility.
After IRB and all relevant subcommittee approvals are obtained, proceed with R&D Committee submission for review and approval.
Schedule the sponsor’s site visit and include the Research Pharmacist and the CSC Manager for this visit.
For contracting issues, contact the AREF Contracts/Grants Administrator.
Receive the CRFs, Study Binder, and supplies from the study sponsor.
Procedures for Industry-Sponsored
Clinical Trials

14. Preparing for a Research Study
For Industry-
Sponsored
Clinical Trials
If the research study involves drugs:
Provide a copy of the Protocol and Investigational Brochure to the Research Pharmacist for review and approval.
Obtain the pharmacy chief’s approval.
Complete an FDA 1572 form (Investigator’s Agreement), if applicable.
Complete VA Form and pharmacy impact form available at:

15. Informed Consent Form Writing Guidelines
VA Consent Template, VA HIPAA Authorization Form, and the VA Revocation Letter are located at:
General Guidelines on Writing a Consent:

16. Approval Process Objectives Policy Principal Investigator’s
Responsibilities
To outline approval processes for the Institutional Review Board (IRB) and the AVAMC’s Officers and Committees.
A final letter of approval must be obtained from the AVAMC’s ACOS/R prior to starting any research activities (this includes screening).
Obtain notification and/or approval for:
The original research protocol submission (IRB and VA approval)
“Continuing Review” (IRB approval only- submit for filing to VA)
Amendments to the original protocol (IRB approval only, *unless there is a change in PI, risk, or data repository. Need *R&D approval* also in those cases).

17. Approval Process SUBCOMMITTEES REVIEW & APPROVAL
Research protocols to be conducted at the Atlanta VA must be submitted to the Emory IRB or VA Central IRB for review and approval.
IRB Submissions are completed online through the Emory eIRB system.
The “Study Application for PO/ISO Review” in eRRRP needs to be submitted prior to IRB review.
All VA protocols are reviewed by an Emory Biomedical IRB Committee.
VA Subcommittee on Research Safety (SRS or aka, “Biosafety”) and VA Radiation Subcommittees approval must be obtained prior to R&D Committee review. The SRS submission can be completed on-line as part of the eRRRP submission process. VA Radiation approval forms are available on-line and must be submitted before R&D committee review.

18. Approval Process
All human research protocols must be reviewed and approved by the AVAMC Sub-Committee on Research Safety (aka- “Biosafety Committee”) regardless of whether there are any blood-borne pathogens, body fluids/specimens, etc. involved in the study.
Human research protocols performed at the VA involving radiation and radioactive materials must be reviewed and approved by the AVAMC Subcommittee on Radiation Safety Committee (RSC).

19. Approval Process
Log on to for submission guidelines and information.
The IRB will notify the PI in writing of their decision to approve, approval pending, defer, or disapprove the protocol.
Once IRB and all applicable subcommittee approvals are obtained, including PO/ISO review, the project can be submitted for R&D review using eRRRP

20. Emory eIRB Submission Checklist
eIRB Initial Submission (requires the Department Chair’s Approval)
Upload CITI training certificate, Key Concepts for PI and CO-I, and Intro to Clinical Research (if applicable)
Upload Lay Summary
Upload Full Protocol
Upload Investigator’s Brochure, if applicable
Upload the VA Informed Consent Form (ICF) into eIRB. Use the “VA Informed Consent Form Template” located on the Atlanta VA research website.
Upload the VA HIPAA Authorization Form into eIRB. Use the “VA HIPAA Authorization template” located on the Atlanta VA research website.
Upload the VA Revocation Form into eIRB. Use the “VA HIPAA Revocation Letter template” located on the Atlanta VA research website.
Oncology protocols must include approval documentation of Winship Cancer Center Review Committee.
Upload recruitment and/or advertisement materials, if applicable, and any letters or other information given to the subject.
Any waiver forms required (Consent, HIPAA, flag waiver, etc.)
HIPAA Worksheet Application for Waiver of Authorization

21. **eRRRP is INTRANET ONLY**
Approval Process
R&D COMMITTEE REVIEW & APPROVAL- ERRRP
Submit protocols for R&D Committee review and approval using eRRRP (electronic request to review research projects):
Website:
The R&D Committee meets on the first Wednesday of each month
Submit complete project through eRRRP no later than the Wednesday prior to the convened meeting.
**eRRRP is INTRANET ONLY**

22. Approval Process
The Principal Investigator submits and the Service Line Chief must electronically sign off through eRRRP.
The Investigator should keep a paper copy of the FINAL, APPROVED submission packet for his/her files.
The R&D Committee may request additional changes after IRB approval has been obtained.
If so, the PI must submit a modification to the IRB.
Study activities (including screening) may not start until the ACOS/R notification of approval letter has been obtained.

23. Approval Process Protocol Modifications
The IRB must approve any changes made to the originally approved investigational plan.
A modification includes: protocol amendments, changes or additions of a procedure, consent form revisions, staff changes, request for recruitment, etc.
Submit the Modification through eIRB. Once approved, study team is responsible for forwarding to the SIO at the AVAMC.
Protocol
Modifications

24. Approval Process Protocol Modifications
Then, the amendment/modification will be communicated to the R&D Committee, and will be included in the minutes of the R&D Committee.
The amendment/modification must be reviewed and approved by the full R&D Committee if there is:
a change in the risk/benefit ratio
a change in the PI
the creation or amendment to a data repository
Protocol
Modifications

25. Approval Process Protocol Modifications
Amendments/modifications involving Privacy, Information Security, BioSafety and/or Radiation will be routed by the SIO to the appropriate individual or subcommittee for review and approval PRIOR to review and approval from the R&D Committee.
Some examples include but are not limited to changes in additional x-ray or radiographic procedures, blood or other tissue collections that are:
not collected in the clinical setting and/or
have not previously been approved by the appropriate subcommittee

26. Approval Process IRB Continuing Review
Continuing reviews are conducted at intervals based on the degree of the risks, but not less frequently than once per year.
Continuing review requests should be submitted to the IRB 45 working days in advance.
For instructions about continuing review submissions, log on to
Provide a copy of the continuing review approval and any updated corresponding forms (if applicable) to the Science Information Office (SIO). is preferred.
It is the PI/Study Staff’s ultimate responsibility to keep up with Continuing Review by not letting the study lapse. Lapses = required reporting to the Office of Research Oversight (ORO).
IRB Continuing
Review

27. Recruitment of Research Subjects
Indirect – The potential subject contacts the study team.
Examples include flyers, advertisements, radio, television, etc. Requires IRB and Office of Public Affairs approvals prior to use.
Direct – The study team contacts the potential subject .
Examples included person-to-person, letter, or telephone. Letters require IRB approval prior to use.
“Cold Calling” is making contact either by person-to-person, letter, or by telephone when the potential subject is not expecting such an interaction.
“Cold Calling” is not allowed at the Atlanta VAMC.

28. Recruitment of Research Subjects
Recruitment Methods:
Recruitment from subjects provider
Provider gives written permission for his patients to be contacted by the study team (permission from the provider is by or letter).
Provider gives out research flyers, etc. to potential subjects
Provider makes an introduction to a research team
Recruitment from the Investigator’s own patients
The Clinician / PI can provide written materials in advance & allow the patient to contact a study team member later if interested or not interested
Another Co-I or member of the study team who is not the treating physician can talk to the subject about the research

29. Recruitment of Research Subjects
Recruitment Letters
Must be on official VA letterhead
Introduction-name study/group
Purpose of study
Participation is voluntary
Participation will have no effect on benefits
Minimize focus on compensation
Provide a contact name, telephone number and schedule-voice mail
Inform subject of any follow-up (date/type)
Letter must originate from PI (Provider may co-sign)

30. Recruitment of Research Subjects
Protect the Confidentiality of Subjects
Provide Equal Opportunity to Participate or Not to Participate
Do not use any diagnosis, prognosis, or treatment language relating to substance abuse, HIV, sickle cell anemia or mental health.
Do not use references to military sexual trauma, PTSD, or STDs, etc.

31. The Informed Consent Process
Outline policies and procedures regarding the Informed Consent Process.
Describe the policies and procedures for the review and documentation of the VA Research Consent Form (VA FORM ) to ensure that research volunteers are consented properly.
Comply with federal guidelines and the Atlanta VAMC policies and procedures regarding the consenting process.
Objectives

32. The Informed Consent Process
Informed Consent Process Definition:
The Informed Consent Process is an exchange of information that takes place between a subject and investigator before, during, and sometimes after the study. Researchers should know that a written document alone will not ensure that individuals fully understand what participation in research means.
Therefore, before, during, and after an individual participates in research, the study team discusses the purpose, procedures, risks and potential benefits, and rights of participants with that individual.

33. The Informed Consent Process
Obtain informed consent from all subjects prior to initiating any study activity.
Use the most current IRB approved VA Form Informed Consent Form (ICF).
Obtain written “HIPAA Authorization” from each subject prior to starting any study activity.
Provide the study subject with the “Revocation Letter”.
When the Principal Investigator (PI) delegates the responsibility of obtaining consent, he/she must ensure that the person is knowledgeable, trained & qualified.
PI must delegate in writing (in protocol or IRB submission) who will be obtaining consent.
Ensure that the consent process is documented in the subject’s electronic medical record (unless waived by the IRB).

34. The Informed Consent Process
The PI oversees compliance regarding the Informed Consent Process according to institutional policies and Federal Regulations.
The IRB and the VA Research Compliance Officer (RCO) have the authority to observe the consenting interview.
The R&D Committee (R&DC) may require additional changes in the consent form after IRB approval. If so, the consent must be re-submitted for IRB review and approval and then returned to the R&DC for final review and approval.
The consent must be written in a language that the subject and/or Legally Authorized Representative (LAR) can understand.
If the protocol is amended, the IRB may require that study participants are re-consented.
Any changes made to the consent, must be submitted to the IRB for review and approval, and then, forwarded to the R&DC for their approval or acknowledgement.

35. The Informed Consent Process
Procedures:
When obtaining written consent, the subject must read, sign and date the consent prior to starting any study activities.
In addition, the ICF must be signed & dated by:
The person obtaining consent.
A witness, IF requested by the IRB.
Allow subjects sufficient time to read the ICF, and consider whether or not they wish to take part in the study.
Provide a copy of the “Volunteering in Research” brochure to the subject. Provide a copy of the NOPP to any non-veteran who will be taking part in a research study.
If necessary, provide or mail a copy of the ICF to the potential study participant prior to a scheduled discussion.
A rushed consent process increases the likelihood of an ill-informed, coerced decision.

36. The Informed Consent Process
Procedures:
Discuss all elements of the consent and ensure that all questions are answered before the subject decides whether or not to participate in the study.
Assess the subject’s ability to read and comprehend the consent document and their understanding about the research and it’s risks by asking a few simple questions.
If the subject’s competency to provide consent is questionable, a clinical assessment is required. This must be done by a clinician that is not part of the study and this must be documented in CPRS in a signed/dated progress note.
Ensure that the subject gives consent without coercion or undue influence.

37. The Informed Consent Process
You Tube Informed Consent Video

38. The Informed Consent Process
Procedures:
The original signed and dated ICF must be kept with
the investigator’s study files.
Provide a copy of the signed and dated consent
form to:
The study subject
The Research Pharmacist (if the study involves drugs)
Scanning in the Computerized Patient Record System (CPRS)
Document the consent process in CPRS. If this is a re-consent, this must be documented also.
Reinforce the study information throughout the course of the study.
“The Informed Consent Process” policy is located on the Atlanta VA research website.

39. The Informed Consent Process
Legally Authorized Representative (LAR) Consent:
Under appropriate conditions, informed consent may be obtained from the subject’s Legally Authorized Representative (LAR) if the prospective research participant is incompetent or has an impaired decision-making capacity.
LAR is an individual or body authorized under applicable law to provide permission, on behalf of a prospective subject, to a subject's participation in the procedure (s) involved in a research study.

40. The Informed Consent Process
The determination of competency must be documented and made according to the following requirements:
The practitioner, in consultation with the chief of service, may determine after a medical evaluation that the subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time.
Consultation with a psychiatrist or licensed psychologist must be obtained when the determination that the prospective research subject lacks decision-making capacity is based on a diagnosis of mental illness.
LAR Consent:

41. The Informed Consent Process
A Legally Authorized Representative (LAR) can be (in this order):
Individuals with durable power of attorney for healthcare
Legal guardians
Spouse
Adult children
Parents of adult children
Siblings
Grandparents
Grandchildren
Close Friend
LAR
Consent:

42. The Informed Consent Process
LAR
Consent:
If possible, explain the proposed research to the prospective subject even when the LAR gives consent.
Under no circumstances may a subject be forced or coerced to participate in a research study.
The same consenting process and requirements followed for subjects, also apply to the subject’s LAR.
Staff should contact the Regional Council regarding any legal questions about a LAR or other legal matters.

43. The Informed Consent Process
The PI or the IRB will determine in which circumstances informed consent may be obtained in an alternative manner.
The IRB may waive the requirement for the consent process (or written documentation) if the research presents no more than minimal risk to study participants.
When this waiver is in effect, the IRB may require that the PI provides a written statement regarding the research to the study subjects.
Procedures For Alternative Informed Consent

44. HIPAA = Health Insurance Portability and Accountability Act
HIPAA & Research
HIPAA = Health Insurance Portability and Accountability Act
Purpose is to ensure that Patient Health Information (PHI) is safe and secured from individuals and entities that are not authorized to use or transfer PHI.
HIPAA regulates how researchers are able to use and access PHI
Research activities are not considered to be part of normal healthcare operations and therefore a HIPAA waiver or signed HIPAA authorization is required

45. HIPAA & Research
The Privacy Rule permits a covered entity (i.e. medical center) to use and disclose PHI for research purposes, without an individual’s authorization, provided the medical center obtains either:
Documentation that an alteration or waiver has been approved by the IRB
The researcher states the use and disclosure of PHI is solely to prepare a research protocol
The researcher describes how PHI is necessary to conduct the research

46. HIPAA (Alteration) Waiver Worksheet
HIPAA & Research
HIPAA & Research
HIPAA (Alteration) Waiver Worksheet
Is a required document and must be completed at time of initial submission
Is found on the AVAMC research website
Describes:
The use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals
That the research could not practicably be conducted without the waiver or alteration
That the research could not practicably be conducted without access to and use of the protected health information.

47. HIPAA & Research HIPAA & Research Types pf HIPAA waivers
Full/Complete: A complete HIPAA waiver allows an investigator to use and disclose PHI for a particular research trial or activity without obtaining either a verbal or written authorization from the participants. It is granted by the IRB.
Partial: A partial HIPAA waiver permits the use of PHI for recruitment purposes only, to allow identification and, as appropriate, contact of potential participants to determine their interest in study participation. It is granted by the IRB.

48. HIPAA & Research
Must have HIPAA authorization signed by subject or have full waiver granted by the IRB if using or disclosing PHI for “research purposes”
The protocol, ICF, eIRB, and eRRRP must be consistent with the HIPAA authorization.
Use the AVAMC template located on the AVAMC research website
VA HIPAA is a stand-alone document
AVAMC Privacy Officer reviews and approves VA HIPAA

49. HIPAA & Research Core Elements of the HIPAA Authorization:
Clear description of the PHI to be used and disclosed (lab results, medical history, HIV diagnosis, demographics ,etc.)
Specific information about the persons or groups authorized to use or disclose PHI (PI, research team, etc.)
To whom the PHI is used or disclosed to (FDA, Sponsor, Emory, etc.)
Description of purpose for use or disclosure
Expiration date
End of research study
None (data repository or registry)
Location where PHI will be stored
Patient rights: to revoke authorization at any time
Signature of subject or LAR

50. 18 HIPAA Identifiers Names
All geographical subdivisions smaller than a state, except the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000
All elements of dates except year and all ages over 89
Phone numbers
Fax numbers
Electronic mail addresses
Social Security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs);
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code the data)

51. HIPAA & Research
Preparatory to Research Data repositories (including VA medical records) may be used (i.e., accessed) by VA investigators for activities that are preparatory to VA research without the requirement to obtain either a HIPAA authorization from the subject or a waiver of HIPAA authorization by an IRB or Privacy Board. This includes use of PHI for the preparation of a research protocol prior to submission to the IRB(s). Preparatory to Research activity is the only instance of access for research purposes allowed in VHA without a written HIPAA authorization signed by the individual, a waiver of HIPAA authorization by an IRB or Privacy Board, or approval by the IRB(s). This access is granted only to VHA researchers.

52. Preparatory to Research
HIPAA & Research
Preparatory to Research
The PI must document in his research files:
1. The access to PHI is only to prepare a protocol;
2. No PHI will be removed from the covered entity (i.e., VHA); and
3. The PHI accessed is necessary for preparation of the research proposed.
Only aggregate data may be recorded and may be used only for background information, to justify the research, or to show that there are adequate numbers of potential subjects
No recording of Individually Identifiable Health Information
No recruiting from the data
Pilot studies are not considered to be “activities preparatory to research”
The preparatory to research activities end once the protocol has been submitted to the IRB and R&D Committee.
Must comply with all VA Data Repository Requirements

53. Data Repository
Data Repository - is a database or a collection of databases that have been created or organized to facilitate the conduct of multiple research protocols, including future protocols not yet envisioned.
Research Data Repository – is a data repository created from data obtained either to conduct a research protocol(s) or gathered in the course of conducting a research protocol and is maintained after the completion of the research protocol
Establishment of Data Repositories need IRB and R&D approval
Require Standard Operating Procedures
Require annual review by IRB and R&D
Releasing data from the repository requires IRB & R&D approval
Data Repository policies and tools are located on the AVAMC research website.

54. HIPAA & Research

55. Scanning Forms into CPRS
Objectives Responsibilities Procedures
Outline scanning procedures for the Informed Consent Form, the HIPAA Form, Revocation Letter (only if signed), VA form , VA form , VA form and VA form
The Principal Investigator (PI) and/or designee ensures that the subject’s signed and dated ICF is scanned in CPRS. Submit scanning request within 72 hours of obtaining consent .
Enter the “Research Consent Progress Note” in CPRS prior to scanning the consent & HIPAA Authorization.
Provide a good quality copy of ICF and HIPAA Authorization form with the subject’s full name and social security number on the bottom of the first page of the document.

56. Scanning Forms into CPRS
Procedures:
Complete the “Scanning Research Request” form for research documents. This form is located on the Atlanta VA website.
Place documents in privacy envelope and drop them at the designated drop mail box at the Clinical Studies Center (Room 11c119). These may include: ICF, HIPAA, Accounting of Disclosure Form, the Notice of Privacy Practices Acknowledgement form ,VA form , VA form , VA form and VA form
Documents are picked-up at the CSC daily and available for viewing in CPRS within 24hrs.
Medical Records scanning staff will shred the ICF paper copy unless otherwise specified .THEREFORE DO NOT SUBMIT THE ORIGINAL FOR SCANNING!
The original ICF is kept by the PI and/or designee.

57. Scanning the Investigational Drug Information Record
Outline procedures for scanning the Investigational Drug Information Record VA Form in CPRS.
Provide additional protection for subjects who are participating in research studies involving drugs.
The PI or designee is responsible for ensuring that the VA Form is scanned in CPRS right after a subject is enrolled in a study involving drugs.
Objectives: Responsibilities:

58. Scanning the Investigational Drug Information Record
Provide a good quality copy of VA Form with the subject’s full name and social security number on the first page of the document.
Complete a “Scanning Request for the Investigational Drug Information Record VA Form ” available at the Atlanta VA research website.
Deliver scanning requests to the Clinical Studies Center (CSC), Room 11C119.
Forms are picked-up at the CSC by 11:00 AM daily, Monday – Friday.
Scanned documents will be available in CPRS for viewing within 24hrs after being picked up.
The medical record scanning team will shred the consent copy after scanning, unless otherwise specified.
The PI and Pharmacy keep a copy of VA Form filed in the study binder.
Procedures:

59. CPRS Documentation Requirements
Document research encounters (face to face or phone) with research subjects in the Computerized Patient Electronic Record (CPRS) system.
CPRS access and training will be provided to staff. To schedule training, contact the Research Training Coordinator at ext
“Research Clinics” are non-billable clinics located in CPRS and are used to :
Document research encounters/visits
Place orders for investigational drug, tests or procedures required solely for the research study
Refer to “Procedure for Setting Up Research Clinics” located on the Atlanta VA website.
“ATL Research Study” is a general clinic location that can be used for studies that will not be impacting a hospital service.
Refer to “CPRS Documentation Requirements” and “Entering Research Progress Note in CPRS” policies located on the Atlanta VA website.

60. Documentation Requirements
Non-Veterans Documentation Procedures:
Create a separate paper chart for non-veteran research participants. Document the consenting process and any other research encounters/visits (if applicable). Keep with study files.
Non-veteran research participants must be entered in VISTA/CPRS system if using a hospital service for a test or procedure that is required as part of the research protocol (e.g. the VA laboratory, radiology, nuclear medicine, etc.).
Refer to “Notice of Privacy Practices for Non-Veterans” (NOPP) policy located on the AVAMC research website.
Contact the CSC for further details and instructions on enrolling a non-Veteran in research.

61. Research Clinics
A “Research Clinic” is a virtual non-billable location created in CPRS to:
Document research encounters and distinguish research versus standard of care visits.
Order investigational drugs and tests/procedures that are above and beyond standard of care.
Avoid billing research participants for research procedures.
Comply with documentation requirements of the informed consent process and research encounters.
A protocol-specific “Research Clinic” location is needed when a research study impacts a hospital service by performing tests and/or procedures solely required for the study. For example: laboratory, radiology, Pulmonary Function Laboratory, Nuclear Medicine, etc.
The Clinical Studies Center handles and oversees the clinic setup process.
The “Procedure For Setting Up Research Clinics” policy may be found on the Atlanta VA website.

62. Regulatory Documents
The Principal Investigator and/or designee is responsible for keeping complete and accurate regulatory documents for the study.
Collect, organize, and maintain all documents in a regulatory binder.
Document everything: “If it isn’t written down, it never happened”.
At the end of the study, store the study binder with other research records. NEVER DESTROY ANY STUDY DOCUMENTS!!!
The “Procedure For Completing Accounting of Disclosure Form For Research” may be found at the Atlanta VA research website.
Please refer to “Regulatory Documents Policy” located on the Atlanta VA research website. This includes the Regulatory Document Checklist.

63. Regulatory Documents Checklist
Protocol and any amended protocols
IRB & R&D approval documentation
Copies of the eIRB initial submission
Copies of the eRRRP submission
Approval letter from ACOS for Research
Approved Informed Consent Form and HIPAA Documents
Modifications forms with supporting documents
Continuing review approval documentation
Reportable Events (SAEs, UPs, SPs, RIIs)
Recruitment materials
IRB, R&D, and Sponsor’s Correspondence
Protocol Termination form

64. Regulatory Documents Checklist
Investigator’s Brochure
Final signed 1572 and amended FDA 1572s
Principal Investigator’s CV
Copy of randomization codes
Investigational article log and copies of drug/device shipment/retrieval
Lab Certification
Accounting of Disclosure Form
Enrollment log
Monitoring visits reports
Research Training Certification
Signature and Delegated Responsibilities Log
Abstracts or manuscripts with study results

65. Source Documents
Source Documents are any forms, records or documents where study data is first recorded. Information captured in source documents includes clinical findings, observations, and other study activities and is used to complete the Case Report Forms (CRFs). Source documents must be attributable, legible, contemporaneous, accurate, complete, & verifiable.
Principal Investigators and/ or designee are responsible for maintaining complete and accurate Source Documents.
Source Documents are important because:
Promote data consistency and ensures that information required for transcription to CRFs is captured.
Verify the subject’s participation in the study as well as data integrity.
It is a “Good Clinical Practice” and is FDA required.
Corrections should be initialed/dated by the person making the correction.
No whiteout or other means of concealing errors should be used on ANY research document.
Please refer to the “Source Documents” policy on the Atlanta VA website.

66. Data Management and Security
Study information that is identifiable, sensitive, and/or has PHI must be saved in the secured server specifically designated for research. Contact the Director of Research Operations for access.
Secure study files in a locked cabinet and in a locked office at the VA. Never leave PHI unattended.
All VA sensitive research information needs to be used and stored within the VA.
A data transfer agreement is required if VA sensitive data is transmitted or removed outside the VA .
PHI and/or identifying information should not be included in the CRFs unless special authorization for a limited data set has been granted.
Social security numbers should not be recorded in the CRFs. Only use a study ID to identify study participants.

67. Data Management and Security
Contact the Information Security Officer (ISO) at VA extension 5081 for information about data transfer agreements and other security issues.
You must have permission from the ISO if any data is going off-site (i.e. Emory).
Laptops and flash drives must be encrypted by the VA if used for transporting data outside the VA.
Know where your data is located and where it is going. This must be stated in the Protocol, ICF and HIPAA forms. Study subjects need to be informed how their PHI is used, accessed, or disclosed .
Report any Research Information Incidents within one hour to ACOS, PO, ISO, and RCO.
Review “VHA Privacy and Information Security Awareness and Rules of Behavior”, “Information Security 201 for Research Personnel”, and “VHA Privacy and HIPAA Training” in LMS for more information or contact any research staff member with questions. The “Data Management” policy is located on the Atlanta VA website.

68. Management of Investigational Drugs
An investigational drug is a medication for which an Investigational New Drug (IND) application has been filed with the Food and Drug Administration (FDA) .
At the VA, an investigational drug is also defined as an approved drug that is being studied for an unapproved or approved use in a controlled, randomized, or blinded clinical trial.
The Principal Investigator (PI) is responsible for complying with VA policy regarding storage and dispensing of investigational drugs.
The Clinical Research Pharmacist , Dr. Mehran Salles, is responsible for assessing the investigational drug feasibility prior to protocol approval. khadijeh.salles-
Provide a completed “Investigational Drug Information Record” VA Form for each drug used in the clinical trial.
Staff working with studies involving drugs are required to take additional training regarding the pharmacy procedures. Training is provided by the Research Pharmacist.

69. Management of Investigational Drugs
Investigational Drug Policies and Forms are located on the Atlanta VA website:
“Investigators Instructions for Placing Orders in CPRS for Investigational Drugs”
“Research Coordinators Instructions for Placing Orders in CPRS for Investigational Drugs”
“Management of Investigational Drugs Procedures”
“Procedures for Scanning the Investigational Drug
Information Record VA Form ”

70. Management of Investigational Drugs
An Investigational device is a device, including a transitional device, that is the object of an investigation. Generally, these devices are not approved by the FDA, or are being tested or studied for indications not previously approved by the FDA.
The Principal Investigator (PI) is responsible for controlling, securing, accounting for, and using Investigational Devices properly.
The Research Compliance officer is responsible for assessing the investigator’s control of investigational devices.
Refer to the “Management of Investigational Devices Procedures” policy on the Atlanta VA website.
Contact the CSC Manager for further guidance.

71. Flagging Medical Records
It is a requirement to post a “Patient Record Flags: Category II” warning in CPRS for VA patients participating in a research study if the study involves:
drugs or devices
an invasive research procedure
Interventions that will be used in the medical care of the subject or could interfere with other care
Clinical services are utilized
Use of a questionnaire that may provoke undue stress or anxiety
Posting a Research Flag lends additional protection to patients that are participating in research studies by informing the subjects’ healthcare providers of their research participation.
Procedures to Post, Remove & Edit Research Flags in CPRS” can be found on the Atlanta VA website.
Please refer to “Category II Medical Record Flag Waiver Policy” on the Atlanta VA website for exemptions.

72. Research Subject Reimbursement
The terms and conditions of reimbursement for research participants should be disclosed in the research proposal.
In the Informed Consent Form, specify the reimbursement amount, payment form (cash, check, etc.), when, and how it will be done.
The investigator must ensure that reimbursements are appropriate, prorated, and do not constitute or appear as undue pressure and/or coercion to the subject.
The investigator may delegate to a research team member the responsibility of handling reimbursements for study participants.
Reimbursement procedures depend on where the funds are managed (VA, Emory, AREF).
Maintain clear documentation of any subject reimbursement.
Refer to “Research Participants Reimbursement Procedures” located on the Atlanta VA website.

73. Reportable Events
The VA requires prompt written reporting to the Atlanta VA Research Administration Office (within 5 days of learning of the event) of the following events:
Serious Adverse Events (SAE)
Serious Problems (SP)
Unanticipated Problems (UP)
Serious Adverse Event: An Adverse Event in human subjects participating in research that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome.
Serious Problem (SP): A serious problem is a problem in human research that may reasonably be regarded as:
Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research subjects, research staff, or others; OR
Substantively compromising the effectiveness of a facility’s human research protection or human research oversight programs.

74. Reportable Events
Unanticipated Adverse Event or Unanticipated Problem (UP) - The adverse event or problem is either new or greater than previously known in terms of nature, severity, or frequency of occurrence. In order for the event to be unanticipated, it cannot be listed in the study protocol, the Informed Consent, Investigator’s Brochure, Sponsor’s Information, or expected in the study population.
Note: “Serious Problems” may include UPs.
Reportable Event Form (REF) – The Reportable Event Form is located on the Atlanta VA website. The PI will complete and submit the REF to the Research Administration Office, who will send to the Institutional Review Board (IRB) member-reviewer.

75. Reportable Events
The PI should scan the completed REF with any attachments and via PKI encryption to David Knight in the Science Information Office at:
By submitting the completed REF to the Science Information Office, the study team has satisfied the local reporting requirement to the IRB.
In the event that Mr. Knight is absent, his will automatically forward other research administrative personnel who will assume responsibility for receipt of the REF.
The “Reportable Event Form”, the “Reportable Event Policy”, as well as Appendices C and D are located on the Atlanta VA website.

76. Reportable Events
The PI is responsible for submitting a summary of the following events at time of Continuing Review to the IRB:
Reportable Events (will have already been reported promptly, but please include these in your summaries). This includes Unanticipated Problems involving risks to subjects and all local SAEs.
May use Appendix C

77. Reportable Events Protocol Deviations (PD)
Definition – A departure from the IRB-approved protocol.
Report PDs to the IRB if there has been a substantive deviation from the protocol that could or did adversely affect at least one of the following:
The rights, welfare, or safety of subjects;
The subjects willingness to continue participation; or
The scientific integrity of research data

78. Reportable Events Non-compliance definition:
“Failure to comply with any of the regulations and policies in the IRB and VA Policies and Procedures and failure to follow the determinations of the IRB”.
Consult the IRB or the VA Research Compliance Officer (RCO) for questions about what to report and how.
Reportable Research Incidents: Incidents, events or problems that involve the unauthorized use, disclosure, transmission, removal, theft, loss, or destruction of VA research-related protected health information (PHI), individually identifiable private information, or confidential information as defined by the HIPAA Privacy Rule, the Common Rule, the Privacy Act or 38 U.S.C. must be reported within 1 hour as described in the AVAMC policy entitled: “Research Information Incidents.” This policy can be found on the AREF website.

79. Research Quality Assurance & Improvement Program
The AVAMC QA/QI Program:
Identifies and corrects deficiencies on an ongoing basis.
Provides ongoing training and education to VA research staff regarding ethical principles and proper research conduct.
Ensures the quality and integrity of data when conducting human research studies.
Ensures regulatory compliance with VA policies and procedures.
Ensures that all study staff adhere to the study protocol for quality and consistency.
Schedules visits annually or on an as needed basis to assess study performance.
After initial review, the RCO will meet with the study coordinator (and PI if necessary) to discuss discrepancies, findings, and to make study performance improvement recommendations.
If corrective actions are needed, the assessment form is submitted to the Emory IRB for review.
The Principal Investigator is responsible for ensuring that research studies are conducted in compliance with federal regulations and institutional policies.
QA policy and forms are available at the Atlanta VA research website.
Quality Assurance / Improvement Program Policy
QA form for general research studies
QA form for drug/device research studies

80. Monitoring & Audit Visits
All study monitors and/or external auditors need to check-in at the CSC and provide a copy of the Entrance Briefing Form to the CSC Administrative Assistant.
Note: No entity other than those listed on the consent and HIPAA form may have access to any documents with Protected Health Information.
All forms and instructions are found on the AREF website:
Procedure for External Monitoring Visits
VHA Privacy Policy Training Instructions for Monitors (if applicable)
Monitoring Visit Report Entrance Briefing Form
Monitoring Visit Report Exit Briefing Form

81. Monitoring & Audit Visits
The monitor is responsible for conveying any potential or actual serious findings to the PI and the
Research Compliance Officer (RCO).
Findings that require an exit interview include, but are not limited to:
Any suspicions or concerns that non-compliance may exist.
Serious non-compliance with the study protocol, Emory Institutional Review Board (IRB) requirements, or applicable regulations and policies such as:
Failure to consent subjects prior to initiating study activities
Enrolling subjects who do not meet study inclusion criteria
Failure to report serious or unexpected adverse events
The research office is required to report to the VA Office of Research Oversight (ORO) all findings of serious non-compliance through the Medical Center Director.
Contact Information:
Research Compliance Officer – Rodney Thompson
Phone: (404) ext Fax: at: (404)

82. Study Close Out Procedures
A study is "closed" when:
All subjects have completed study participation
Data collection is completed
The sponsor decides to terminate the study and/or completes a study close out visit
Data analysis is complete
The Principal Investigator (PI) and/or designee is responsible for following the “Procedures for Closing Research Studies”. The policy is located on the Atlanta VA website.
Close out the study with the R&D Office by turning in the following via to the SIO:
A copy of the IRB Close Out approval letter
An end of study summary abstract
RCO needs to review study prior to preparation of study files for short term or long term storage.
Ensure that all electronic study identifying information has been saved in the secured research server.
Never destroy any research data and store ALL data at a VA storage facility indefinitely.

83. Research Records Retention & Storage
The VA Central Office (VACO) requires that research records be stored indefinitely.
Research records are the responsibility and property of the VA Medical Center.
The Atlanta VAMC is responsible for storage and retention of research records of studies that have been closed.
The PI is responsible for preparing and submitting research records for storage when the study is closed.
Contact the CSC Administrative Assistant (AA) and/or Manager to get boxes and receive instructions to prepare records for storage.
Submit a completed “Research Records Storage Request” by to the CSC AA, prior to submitting records for storage. The request form is available on the Atlanta VA research website. Also refer to the “Research Record Retention & Storage Policy”.

84. Staff Credentialing & Training Requirements
In order to be engaged in research at the Atlanta VA, Investigators must have a VA appointment or a collaborator (Co-PI) who is a VA staff physician or a practitioner with VA privileges.
Physicians may get a WOC (without compensation) appointment; however, they must be sponsored by a clinical division and privileged through the VA Medical Center Chief of Staff Office.
All RNs, LPNs, MDs, and other licensed personnel must complete VetPro  credentialing prior to engaging with research subjects. Specific duties and role as a research coordinator vs. research nurse should be discussed with Antonio Laracuente prior to engagement in research.
CITI certification must be updated every two years on your anniversary date. There is no grace period. Please view “Credentialing to Engage in Human Subjects Research” presentation located on the research website.

85. Staff Credentialing & Training Requirements
All study staff members involved directly or indirectly in the study, must be listed in eIRB under study staff.
If staff is involved in transporting hazardous materials, they must complete the packaging and shipping training in CITI named “Packaging and Shipping of Class 6.2 Agents”.
VA appointments are handled by the VA Medical Staff Coordinator, Dedra Freedman: .
For credentialing and training specifics, contact Nakela Jackson, the Research Training Coordinator at (404) ext or check on the Atlanta VA or AREF website.

86. Research Related Web Sites
Atlanta VA Website: Atlanta VA forms and policies: Atlanta Research & Education Foundation Website: Emory IRB Web Page: Collaborative IRB Training Initiative (CITI): Office of Human Research Protection (OHRP): Office of Research Oversight (ORO) vaww1.va.gov/oro/ Public Responsibility in Medical Research: National Institute of Health (NIH): Food and Drug Administration (FDA): FDA Information Sheets: 45 CFR 50 Protection of Human Subjects: Research Professional Organizations: Society of Clinical Research Associates (SOCRA): Association of Clinical Research Professionals (ACRP): Public Responsibilities in Medicine and Research (PRIM&R):

87. Research Agreements with Collaborators
The Principal Investigator (PI) or designee is responsible for contacting the AREF Contracts/Grants Administrator and informing him/her of his/her interest in participating in an industry-sponsored clinical trial.
The PI is required to provide AREF with a completed Assessment of Clinical Impact Form located on the Atlanta VA website, outlining the obligations of the study for the Atlanta VA Medical Center and a copy of the study protocol. Instructions can be found on the Atlanta VA website.
The AREF Contracts/Grants Administrator is responsible for the legal review and final negotiation of agreements, including the budget.
All research projects administered by AREF must have a signed agreement between the Collaborator and AREF. VA Research & Development (R&D) Committee approval may be sought simultaneously while establishing the AREF contract.
As a general rule, no research funds should be expended until IRB and R&D (ACOS/R) approval have been obtained. However, reasonable and usual preliminary costs for project planning prior to approval are allowable according to VA policy. For AREF administered studies, PIs must have a signed agreement before studies are initiated (= enrollment of first study subject).

88. Clinical Studies Center
The Clinical Studies Center (CSC) is a controlled and professional research center designed to promote and facilitate clinical research for human subjects at the Atlanta VA Medical Center.
The CSC is designed to conduct outpatient research studies and is located on the 11th floor at the Atlanta VAMC.
The Clinical Studies Center consists of the following:
Administrative offices: Medical Director, CSC Manager, and Administrative Assistant
Two Workstations: for research coordinators and study monitors
Five exam rooms: equipped with exam tables, vital signs monitoring machine, X-ray view box, phlebotomy chairs, ophthalmoscope/otoscope, and computer access

89. Clinical Studies Center
On site record storage for studies which have been closed
A laboratory to prepare research specimens for shipping or
storage. This includes:
Bio-Safety cabinet
-80°C freezer
Refrigerator
Centrifuge
Refrigerated centrifuge
Dry ice

90. Clinical Studies Center
To reserve an exam or interview room at the CSC, the CSC Room Request Form to the CSC Administrative Assistant or CSC Manager with the following information :
Room type (exam/interview/monitor station)
Requestor’s name
Study Name
Date, time, and length of time needed
Please do NOT enter subject name, initials, or any identifiers (study ID only)
People using the CSC rooms are responsible for greeting participants in a timely manner and notifying the CSC of appointment cancellations.
The “Clinical Studies Center Operating Guidelines” are located on the Atlanta VA website.

91. Clinical Studies Center Staff
Lawrence Phillips, MD is the Clinical Studies Center Medical Director. He is a Professor of Medicine and Associate Professor of Physiology, appointed to the Division of Endocrinology. In the past, he served as the Director of Endocrinology and Program Director of the Emory University GCRC. He served on the Editorial Boards for the journals Diabetes and Endocrinology, and as a member of the NIDDK- B NIH Study Section that reviews grants. He is experienced in training Junior Faculty members and Fellows who have gone on to pursue an academic career in clinical investigations. Dr. Phillips is experienced in peer-review standards for research quality as exemplified by the awarding of extramural research support, and is personally involved in clinical investigations on a daily basis. Dr. Phillips currently directs the Atlanta VA Clinical Studies Center Investigator Mentoring Program. He interacts, mentors, and trains VA junior investigators at multiple levels.

92. Clinical Studies Center Staff
Jane Guidot, RN, CCRC is the Clinical Studies Center Manager.
Jane has been a clinical research coordinator at the Atlanta VAMC since She has worked with the cardiology, infectious disease, neurology, pulmonary, and vascular surgery departments on a large variety of projects. She has also worked as a research coordinator at Emory University.  She has served on a variety of committees concerned with the conduct of human research.
She is responsible for the day-to-day operations of the CSC and for providing training and education to Investigators and Research Coordinators involved in human subjects research.

93. Clinical Studies Center Staff
Laurie Hunt, MPH, CIP, is the Human Studies Analyst (HSA). She provides guidance and support to research staff with initial and ongoing human research projects conducted at the Atlanta VAMC. The HSA services include assistance with:
Protocol Submissions to the Emory IRB, VA R&D and CIRB
Committees
Informed Consent Form writing/formatting & HIPAA requirements and documents
Tissue Banking and Data Repositories
Project queries
Continuing Reviews
Modifications and/or Amendments
Information on changes in Policies and Procedures within the
HRPP

94. Clinical Studies Center Staff
David Worley is the CSC Administrative Assistant.  He has extensive knowledge of the Atlanta VAMC, VA policies and VA procedures.  His office is located at the CSC in room 11C119.  He is a veteran with 22 years of active service in the US Air Force.  
He supports research teams and the CSC on a daily basis. His responsibilities include: staffing the CSC office, greeting study subjects, scheduling CSC exam rooms, control and storage  of long and short term  study records, IT requests for CSC personnel, submitting CSC clinic setups in CPRS, problem solving, and many other day-to-day tasks associated with operating the CSC.

95. VA Contact Information
Associate Chief of Staff, Research Services
Michael Hart, MD
(404)
Director, Research Operations
Antonio Laracuente, MBA
(404)
Science Information Officer
David Knight
Ext. 4827
Research Compliance Officer (RCO)
Rodney Thompson
Ext. 6964
Fax (404)
Research Compliance Auditor
Research Pharmacist
Mehran Salles, Pharm D
Ext. 4214, Pager (404)
Fax (404)

96. CSC Contact Information
Medical Director, Clinical Studies Center
Lawrence Phillips, MD
Ext. 7608
Manager, Clinical Studies Center
Jane Guidot, RN, CCRC
Ext. 6933
Fax (404)
Human Research Protections Program Manager
Jennifer Whelan
Ext. 3452
Human Studies Analyst
Laurie Hunt, MPH, CIP
Ext. 4750
CSC Administrative Assistant, Clinical Studies Center
David Worley
Ext. 4934
Fax (404)

97. IRB Contact Information
Emory IRB Office Location: 1599 Clifton Road 5th floor, Room 213 Atlanta, GA IRB Office Numbers: Phone: (404) Toll free: Fax: (404) IRB Department
IRB Director:
Rebecca Rousselle
(404)  
VA/IRB Liaison
Daniel Roysden, PhD, ThM
(404)

98. AREF Contact Information
Main Office Phone Number: (404) Fax (404) AREF Controller Jenna Zargon Ext Fax (404)
Chief Operating Officer AREF Leslie Henry Ext Human Resources Manager Ellen Schneider Ext WOC Coordinator Nakela Jackson Ext