Research Turn Around Times - ICH GCP

Question 1

The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least (blank) after completion of the trial and make them available upon request from the regulatory authority(ies).

Answer 1

3 years

Question 2

The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least (blank).

Answer 2

once per year

Question 3

Essential documents should be retained until at least (blank) after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least (blank) have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained.

Answer 3

2 years; 2 years

Question 4

The sponsor specific essential documents should be retained until at least (blank) after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least (blank) have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirement(s) or if needed by the sponsor.

Answer 4

2 years; 2 years

Question 5

If the sponsor discontinues the clinical development of an investigational product (i.e. for any or all indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific essential documents for at least (blank) after formal discontinuation or in conformance with the applicable regulatory requirement(s).

Answer 5

2 years