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ACRP CCRC ICH GCP - Essential Documents questions n answers
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ACRP CCRC ICH GCP - Essential Documents questions n answers
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ACRP CCRC ICH GCP - EssentialDocuments
What is meant by the term "Essential Documents for the Conduct of a Clinical Trial" - correct answer
✔✔Essential Documents are those documents that individually and collectively permit evaluation of the
conduct of a trial and the quality of data
What ancillary purposes do essential documents serve - correct answer ✔✔Essential documents assist in
trial management, serve as an audit base, and confirm the integrity of collected data
Essential documents pertain to what three phases of the trial - correct answer ✔✔Essential documents
govern the pre-trial activities, the actual trial conduct and the follow-up activities
When is it permissible to combine essential documents - correct answer ✔✔Some documents can be
combined provided that the individual elements are readily identifiable
Where should the trial master files be kept - correct answer ✔✔The trial master files should be kept at
both the investigator/institution's site at at the sponsor's office
When should trial master files be established - correct answer ✔✔Trial master files should be
established at the beginning of the trial
When can a final closeout of a trial be done - correct answer ✔✔A final closeout can only be done when
the monitor has reviewed both the investigator/institution and the sponsor files and confirmed that all
necessary documents are in the appropriate files
Who performs the final closeout of a trial and what goes that entail - correct answer ✔✔The sponsor
closes the trial after reviewing both the investigator/institution's and the sponsor's files confirming that
all necessary documents are in the appropriate files
Who is required maintain a record of the location of their respective essential documents - correct
answer ✔✔Both the sponsor and the investigator/institution should maintain a record of the document
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