CRC Foundations - Clinical Research Coordinator (CRC) Responsibilities
How many reads of the research plan are essential by the CRC? A) Multiple reads through to understand it thoroughly B) None, as long as the PI reads it C) One thorough read D) One quick read for general familiarity
Multiple reads through to understand it thoroughly *Because the research coordinator is often the "face" of the study and may be the one with the most interaction with research subjects, research plan expertise is needed and this requires multiple reads of the plans to know it thoroughly.
Which of the following represents the two skills integral to a CRC's success? A) People skills and diplomacy B) Organization and thoroughness C) Documentation and analytical skills D) Thoroughness and persuasiveness
Organization and thoroughness *While it could be argued that all of these skills come into play at some time, those most integral to success in research coordination are organization and thoroughness.
Complete study documentation to the point of: A) Ensuring you have sufficient proof to show what you completed (for legal evidence) B) Recreating what has transpired C) What is required by sponsor D) The minimum required by the regulations
Recreating what has transpired *While guidance about documentation is found in the regulations with more specifics provided from the sponsor, it is important to document what transpired on a study to the point that replication of the trial would yield comparable results.
Which document identifies which tasks are to be performed by each study staff member? A) DOA log B) Site signature log C) Subject enrollment log D) DOE log
DOA log *The DOA log documents assigned responsibilities of all members of the study staff and often incorporates a site signature log, which can be used to compare signatures and initials, if needed.
What should you access first to become familiar with a new study? A) Initiation visit training materials B) Research plan C) Investigator's Brochure (IB) D) Informed consent documentation
Research plan *Members of the study staff should first read the research plan to learn about the study.
Query resolution requires the study team member to go back to which of the following? A) Study plan and CRFs B) Source documents and CRFs C) Regulatory Binder and subject binders D) Source documents
Source documents and CRFs *To resolve a query, the original data must be verified and this is done by reviewing the original source documents and submitted CRFs.
With regards to investigational products, which of the following is true? A) The research plan identifies what to do with any leftover investigational products B) Research subjects should destroy any unused medications after reporting how many are left C) Leftover investigational products should always be returned to the study sponsor D) It is not necessary to inventory any returned investigational product as the sponsor will do this upon receipt
The research plan identifies what to do with any leftover investigational products *There can be considerable variation in how leftover product should be handled, so it is essential to refer back to the research plan to see each study's specifications.
Where would you likely find completed case report forms (CRFs)? A) The Regulatory Binder B) No need to keep these once submitted C) The subject binder D) The study coordination binder
The subject binder *Because a completed CRF is specific to a study subject, the form should be filed in the subject binder (also called research chart) for that subject.