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

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.

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).

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)

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

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.

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

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

Consenting

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

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

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

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

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.

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

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

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

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.

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.

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

Thank you!