GCDMP - Data Storage

Question 1

What is physical data storage?

Answer 1

All paper and electronic data that is stored in a physical location (this location must be secured).

Question 2

Should physical data storage be safeguarded?

Answer 2

Yes, safeguards like passwords and access-permission controls are vital to ensure that only authorized personnel may access the study data.

Question 3

Database validation and documentation are the ___________ of a secure and reliable system

Answer 3

Cornerstone

Question 4

All validation and user acceptance documentation does not need to be readily available to study personnel. True or False?

Answer 4

False

Question 5

Is the need for thorough validation and trial database design more or less critical for trials utilizing electronic data collection?

Answer 5

More critical

Question 6

A thorough archive includes:

Answer 6

Database design specs, raw data, audit trail, final data, original study docs, procedural variation docs, database closure, site copies of data.

Question 7

NOT A FLASH CARD:

RECOMMENDED DATA STORAGE SOPs

Answer 7

Database validation, database design, database closure, storage of original docs during and after trial, forms management and e-data management, version/change control for revisions to software/hardware/data/documentation, disaster recovery, system controls and security.