Archiving

Question 1

Where are regulatory documents collected and filed?

Answer 1

Collected under supervision of trial sponsor and REB.

Filed in sponsor-provided individual binders or individual file boxes.

Question 2

Where are source documents collected and kept?

Answer 2

Individual patient binders stored in secure area of clinic in locked metal cupboards.

Question 3

Source documents for registries are stored where?

Answer 3

Locked room in different area of clinic than interventional trial source.

Question 4

Direct access to clinical trial records is limited to whom?

Answer 4

Research staff, sponsors, regulatory authorities.

Question 5

Prior to being archived, all records must be placed in banker’s boxes and labelled with what information?

Answer 5

• Site name
• Sponsor name
• Protocol number
• Archiving date
• “Research documents — do not destroy”
• Additional neon-coloured “do not destroy” labels, two per box

Question 6

Archived documents may be moved to secure facilities at _____ under the direction of the trial sponsor under whose instigation?

Answer 6

Iron Mountain.

Sponsor’s or investigator’s.