Records Flashcards
FDA Record Retention
theinvestigator has to keep for 2 years after marketing approval in US or if no application, 2 years after the investigation is terminated & the FDA is notified
ICH Essential Documents:
-Permit evaluation of coduct & data quality
Source docs
IBs
ICFs
CVs
IP Documentation
Before, during, after trial essential documents
ICH Record Retention
2 years after the last marketing application approval & no more applications are pending
or
2 years since formal discontinuation of clinical development of IP
IP GCP Record Keeping
Receipt, storage, dispensing, return & reconciliation of IP, responsibility of the investigator
Records/Reports
Good documentation proves a study was conducted properly
Source data
All original & certified copies necessary to reconstruct & evaluate a trial
Source document
Info, observation, or data is recorded (original)
Documents, data, records, notes, diaries, x-rays, pharmacy records
Only way to copy is a certified copy
Treament code list for double-blinded
treatment code list accessible 24 hours a day in event of emergency, but protected from accidental unblinding
What is a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject?
Case report form (CRF)
What is the proper way to make a correct to the CRF?
Add the initials of the person making the change, date of the change, and if necessary a brief explanation of the change, should not obscure the original entry, maintain a record of hcanges and corrections to source doucments
Why are clinical investigations monitored?
to make sure subjects’ rights, safety, and welfare are being protected
to make sure the site is in compliance with applicable regulations, sponsor requirements, and potentially international standards
to ensure data are complete and accurate
