Seven tips for managing a clinical trial
The main role of a study coordinator is to act as a patient advocate, yet still maintain the integrity and progress of the trial, says Laurie Czaplewski, RN, BSN, clinical trial coordinator with the Mayo Alliance for Clinical Trials in Rochester, MN.
Here are Czaplewski’s seven key strategies for successfully managing a trial:
1. Know the protocol. Read the protocol over several times until you have an excellent understanding of it. Make notes as you read, if necessary, and flag certain areas for quick reference.
2. Know the regulations that govern clinical research and good clinical practice. It is crucial that all individuals involved in research adhere to the Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) Guidelines. Handbooks, which every coordinator should have access to, are available for easy and quick reference.
3. Know your resources. Know where to find additional information and maintain a list of references and resources. Examples: handbooks, Internet sites, local IRB, and other colleagues.
4. Maintain communication. Communicate on a regular basis with the sponsor, monitor, investigators, and other study staff.
5. Document, document, document. It’s crucial to know what to document and where to document it. Develop a system before the study begins to determine what will be documented and where the documentation will be stored. Remember, if it wasn’t documented, it wasn’t done.
6. Be organized. It’s one thing to keep everything, but it’s quite another to be able to find it when you need it. Set up a filing system at the beginning of the study and maintain consistency with it during the course of the trial. Use checklists and to-do lists and set these up on a weekly and daily basis.
7. Develop a timeline and adhere to it. Set specific dates for certain tasks to be complete and then stick to the schedule.
The main role of a study coordinator is to act as a patient advocate, yet still maintain the integrity and progress of the trial, says Laurie Czaplewski, RN, BSN, clinical trial coordinator with the Mayo Alliance for Clinical Trials in Rochester, MN.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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