1. The Role and Responsibilities of the Clinical Research Coordinator
Presented by:
Alexandra Lansky, MD

2. I/we have no real or apparent conflicts of interest to report.
Alexandra J. Lansky, MD
I/we have no real or apparent conflicts of interest to report.

3. Clinical Research Coordinator Role and Responsibilities?
The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI).

4. Reviewing a Potentially New Protocol
Review New Protocol –
Do you have the resources to do this study?
Do you have the patient population to meet enrollment expectations?
Do you have the equipment needed to conduct the study?
Ultrasound
CT Scan
Lab
Refrigerated Centrifuge
-20 Degree Freezer; -70 Degree Freezer
Dry Ice
Space to store the devices? (Research devices will need to be stored in a locked limited access area)

5. IRB Submission Institutional Review Board Purpose - Will Review-
Ethical conduct of the study
Looks out for the patient
Will Review-
Protocol
Instructions For Use (device directions)
Investigational Drug Brochures
Patient Informed Consent – is this document written at an 8th grade level?
Patient Materials

7. Contracts and Budgets Contracts Budget
Each protocol will have a contract
Contracts will be reviewed by various individuals (organization specific)
Budget
Many coordinators will complete the budget
Things to consider:
Know the cost of procedures – review charge master
What is considered research?
Account for coordinators time for screening, enrolling, completing case report forms, IRB submissions, training, investigator meetings, etc.

8. Study Start Up
Protocol Training – investigators, coordinators, departments that maybe impacted by the study
Coordinator Training on data collection
Setting up “Source Document Tools”
Logging in investigational devices or drugs

9. Maintaining Regulatory Binders
Each Study will have a Regulatory Binder.
Binder includes:
Protocol
Device or Drug Information
CVs and Licenses (must always be current)
Lab Credentials (Normal Ranges, CAP, CLIA)
Protocol Training Documents
Delegation Logs
Copies of ALL communications
Consents
IRB Communications
Financial Disclosures

10. Consenting

11. Consenting Subjects
Consent Form must be approved by the sponsor and the IRB
Consent must be in the subject’s native language
Subject should be given the opportunity to read the entire consent
Subject should be given time to ask questions and have their questions answered to their satisfaction
Subject should be given a copy of the signed consent form
The consenting process should be clearly documented
A copy of the consent should be part of the subjects medical record and part of their research chart

12. Screening Subjects
Will need to Screen subjects for possible enrollment
Subjects need to be consented before they can be screened
Know protocol inclusion /exclusion
Obtain protocol required labs – know study requirements
Review medical history
Review subject medications
Review allergies

13. Enrolling Subjects
The actual time of enrollment will be protocol specific
Can be when the consent is signed and dated
Can occur when the subject is randomized
Can occur when the investigation device is inserted
Other
Document, Document, Document!! If it’s not documented it wasn’t done. All information collected for a study has to have a source document. Source documents need to be signed and dated!
Subjects have the right to withdraw from the study at anytime

14. The Protocol
“Nurse, get on the internet, go to
Research Protocol.com, scroll down and click on the ‘Are you totally lost? icon.”

15. The Research Protocol
The Research Protocol is the step by step “directions” for the conduct of the study.
All steps need to be followed! If steps are missed, the coordinator will need to submit protocol deviations, more paper work!
The protocol can be amended during the course of the study. If this occurs, the coordinator will need to notify the IRB of the amendment prior to the implementation of the amendment.

16. Documentation and Data Entry
The coordinator will gather all source documents for data entry.
Study data is submitted to the sponsor
Electronically -eCRF
Paper
There are many electronic data systems that the coordinator will need to know how to use
Data entered in many cases will be source verified by a study monitor
If discrepancies are identified, queries will be submitted for data clarification
Investigator reviews all data and signs all data forms

18. Device and Drug Accountability
Study Devices and Study Medications
Must be “logged” in by the coordinator
Must be stored in a locked limited access area
Must be logged as used
Devices – must track expiration dates, lot numbers and serial numbers (device stickers)
Drugs –
Must track expiration dates, lot numbers and serial numbers
Must track # of pills dispensed
Pill containers and remaining medication must be returned at each scheduled visit to determine subject compliance

19. Subject Follow-Up
Subject duration in a study can last from a day to a life time. The coordinator is responsible for making sure the subject complies with follow-up.
If the coordinator can’t find a patient:
Need to make 3 documented phone attempts
Contact their physician to see if they have an alternative contact #
Send a certified letter to the subject’s last know address
Document, Document, Document!
Search the Social Security Death Index

20. Reporting Adverse Events
Whenever a subject is seen, the subject should be evaluated for possible adverse events.
Adverse events are things that the subject reports that have occurred since they have entered the study. (nausea, headaches, chest pain, etc.)
Serious Adverse Events will need to be reported in a timely manner to the study sponsor and the IRB.

22. Monitoring Visits
Many studies will be routinely monitored to assure protocol compliance.
Monitors will review:
Consents
Case Report Forms
Regulatory Binders
Device/Drug Accountability
Coordinators and the Principal Investigator will need to meet with study monitors on a routine basis.

23. Study Closure The Coordinator will:
Confirm all case report forms have been completed
All queries have been answered
All documents are signed
All study documents have been filled
All study specific devices/drugs have been returned to the sponsor or destroyed
IRB has been notified of study closure
Study documents have been archived

24. Thank you!