Records

Question 1

FDA Record Retention

Answer 1

the site 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

Question 2

ICH Essential Documents:
-Permit evaluation of coduct & data quality

Answer 2

Source docs
IBs
ICFs
CVs
IP Documentation
Before, during, after trial essential documents

Question 3

ICH Record Retention

Answer 3

2 years after the last marketing application approval & no more applciations are pending

or

2 years since formal discontinuation of clinical development of IP

Question 4

IP GCP Record Keeping

Answer 4

Receipt, storage, dispensing, return & reconciliation of IP, responsibility of the investigator

Question 5

Records/Reports

Answer 5

Good documentation proves a study was conducted properly

Question 6

Source data

Answer 6

All original & certified copies necessary to reconstruct & evaluate a trial

Question 7

Source document

Answer 7

Info, observation, or data is recorded (original)
Documents, data, records, notes, diaries, x-rays, pharmacy records

Only way to copy is a certified copy

Question 8

Treament code list for double-blinded

Answer 8

treatment code list accessible 24 hours a day in event of emergency, but protected from accidental unblinding

Question 9

What is the proper way to make a correct to the CRF?

Answer 9

Add the initials of the person making the change, date of the change, and if necessary a brief explanation of the change, single line through

Question 10

Why are clinical investigations monitored?

Answer 10

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