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Presentation on theme: "WELCOME TO THE ATLANTA VA MEDICAL CENTER"— Presentation transcript:

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. Use this template to create Intranet web pages for your workgroup or project. You can modify the sample content to add your own information, and you can even change the structure of the web site by adding and removing slides. The navigation controls are on the slide master. To change them, on the View menu, point to Master, then choose Slide Master. To add or remove hyperlinks on text or objects, or to change existing hyperlinks, select the text or object, then choose Hyperlink from the Insert menu. When you’re finished customizing, delete these notes to save space in your final HTML files. For more information, ask the Answer Wizard about: The Slide Master Hyperlinks 3/11/2013

2 Atlanta VA Medical Center Research webpage location:
Clinical Studies Center forms and policies are located at: 3/11/2013

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 3/11/2013

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. 3/11/2013

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. 3/11/2013

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. 3/11/2013

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: 3/11/2013

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. 3/11/2013

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. 3/11/2013

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 this 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. Be available for the study sponsor monitoring visits to discuss and review study data. 3/11/2013

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. 3/11/2013

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: . 3/11/2013

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 3/11/2013

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: 3/11/2013

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: 3/11/2013

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 or risk. Need *R&D approval* also in those cases). 3/11/2013

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. 3/11/2013

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). 3/11/2013

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 3/11/2013

20 Emory eIRB Submission Checklist
eIRB Initial Submission (requires the Department Chair’s Approval) CITI training certificate Lay Summary (must be entered or up-loaded) Full Protocol (must be up-loaded) Investigator’s Brochure, if applicable (up-load a copy) Upload the VA Informed Consent Form (ICF) into eIRB. Use the "Stamping Template” found on the Atlanta VA website. Upload the VA HIPAA Authorization Form into eIRB. Use the "Stamping Template” found on the Atlanta VA website. Upload the VA Revocation Form into eIRB. Use the "Stamping Template” found on the Atlanta VA website. Oncology protocols must include approval documentation of Winship Cancer Center Review Committee. Recruitment and/or advertisement materials, if applicable,(must be up-loaded) 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 3/11/2013

Submit protocols for R&D Committee review and approval using eRRRP (electronic request to review research projects). **eRRRP is INTRANET ONLY** 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. 3/11/2013

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. 3/11/2013

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 3/11/2013

24 Approval Process 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 Protocol Modifications 3/11/2013

25 Approval Process Protocol Modifications
Amendments/modifications involving BioSafety and/or Radiation will be routed by the SIO to the appropriate subcommittee for review and approval PRIOR to review and approval from the R&D Committee. Some examples include but are not limited to 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 3/11/2013

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 and not letting the study lapse. Lapses=required reporting to the Office of Research Oversight (ORO). 3/11/2013

27 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 3/11/2013

28 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. 3/11/2013

29 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). 3/11/2013

30 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. 3/11/2013

31 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 receive clinical services as a result of 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. 3/11/2013

32 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. 3/11/2013

33 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. 3/11/2013

34 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. 3/11/2013

35 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: 3/11/2013

36 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: 3/11/2013

37 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. 3/11/2013

38 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 3/11/2013

39 The Informed Consent Process
Procedures for Alternative Informed Consent If the standard written consent cannot be obtained, an IRB approved written summary that embodies the elements of the ICF can be read to the subject. An unbiased person should witness the oral presentation. Whenever possible, the subject must sign the “short form” of the oral consent. The witness (if required) and person obtaining consent must sign and date the short form and summary. A copy of both the short form and summary is provided to the subject and the witness. 3/11/2013

40 The Informed Consent Process
Obtaining consent shall be deemed feasible unless both the Investigator and another physician who is not otherwise participating in the clinical investigation certifies in writing all of the following: The subject is confronted by a life-threatening situation needing the use of the test article. Consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent from the subject. Time is not sufficient to obtain consent from the subject's legal representative. There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject. Exception from General Requirements 3/11/2013

41 The Informed Consent Process
The approval for the above-mentioned situation is called emergency or compassionate use of an investigational article. This usage must be reported to the IRB immediately and cannot be planned in lieu of standard consent methods. Exception from General Requirements 3/11/2013

42 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 , 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. 3/11/2013

43 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 , 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. 3/11/2013

44 Scanning the Investigational Drug Information Record VA Form 10-9012
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: 3/11/2013

45 Scanning the Investigational Drug Information Record VA Form 10-9012
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: 3/11/2013

46 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.6177. “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. 3/11/2013

47 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 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.). Contact the CSC for further details and instructions on enrolling a non-Veteran in research. 3/11/2013

48 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. 3/11/2013

49 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. 3/11/2013

50 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 3/11/2013

51 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 3/11/2013

52 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. 3/11/2013

53 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. 3/11/2013

54 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. 3/11/2013

55 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. 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. 3/11/2013

56 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 ” 3/11/2013

57 Management of Investigational Devices
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. 3/11/2013

58 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. 3/11/2013

59 Research Subject Reimbursement Procedures
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. 3/11/2013

60 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. 3/11/2013

61 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. . 3/11/2013

62 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: as well as Jane Guidot 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 and Ms. Guidot are absent, their will automatically forward to the DRO, Antonio Laracuente or 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. 3/11/2013

63 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 3/11/2013

64 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 3/11/2013

65 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. 3/11/2013

66 Research Quality Assurance / Improvement Program
The 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 3/11/2013

67 Monitoring & Audit Visits
Monitors and/or external auditors must complete the “Privacy and HIPAA Training” and “VA Privacy and Information Security Awareness and Rules of Behavior” prior to having access to the research participant’s Protected Health Information (PHI). Instructions are found on the AREF website. All study monitors and/or external auditors need to check-in at the CSC and provide a copy of the privacy training certificates of completion as well as the “Monitoring Visit Report 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 Monitoring Visit Report Entrance Briefing Form Monitoring Visit Report Exit Briefing Form 3/11/2013

68 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: Libby Lively, Research Compliance Officer Phone: (404) ext Fax: at: (404) 3/11/2013

69 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. 3/11/2013

70 Research Records Retention & Storage.
The VA Central Office (VACO) requires that research records are 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 Director 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 website. Also refer to the “Research Record Retention & Storage Policy”. 3/11/2013

71 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, and MDs 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. 3/11/2013

72 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. 3/11/2013

73 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) 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): 3/11/2013

74 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). 3/11/2013

75 Resources Available for Conducting Research
Space : Clinical Studies Center (CSC) Personnel: CSC Staff Research Administration IRB Liaison Human Studies Analyst Compliance Office 3/11/2013

76 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 center is designed to conduct outpatient research studies and is located on the 11th floor of 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 3/11/2013

77 Clinical Studies Center
On site record storage for studies which have been closed A laboratory to prepare research specimens for shipping or storage that is equipped with : Bio-Safety cabinet -80°C freezer Refrigerator Centrifuge Refrigerated centrifuge Dry ice 3/11/2013

78 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. 3/11/2013

79 CSC 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. 3/11/2013

80 CSC 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. 3/11/2013

81 CSC 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 3/11/2013

82 CSC 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. 3/11/2013

83 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) Libby Lively Ext. 6964 Fax (404) Research Compliance Auditor Jennifer Whelan Ext. 3452 Research Pharmacist Mehran Salles, Pharm D Ext. 4214, Pager (404) Fax (404)

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

85 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: Sarah Browning Putney, JD (404)   VA/IRB Liaison Jim Henderson (404) 3/11/2013

86 AREF Contact Information Main Office Phone Number: (404) Fax (404) Administrative Assistant Ext 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 3/11/2013


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