Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GCP.

Minimum period

Retain for at least 5 years.

Comment

This may be longer for some trials.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GCP.

Minimum period

Retain for 5 years after end of the trial.

Comment

The sponsor of the trial is responsible for the destruction of unused and/or returned trial material. Therefore any destruction must be authorised in writing and a dated destruction certificate supplied to the sponsor.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement. Records should also be kept for reference and to demonstrate compliance with GCP.

Minimum period

Retain for 5 years after end of the trial.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GCP.

Minimum period

Retain for 5 years after end of the trial.

Comment

If the activity is aseptic dispensing, then this record becomes part of the Trial Master file and the sponsor should ensure that it is kept for at least 5 years after the conclusion of the trial.

If the sponsor is going to use the data to submit a marketing authorisation application, longer periods are required. This is usually dictated by the sponsor when the contract is set up (often 25 years) and is mandated in GCP as 15 years after completion or discontinuation of the trial, or 2 years after the MA is granted, or 2 years after IMP development is officially stopped.

Provenance

• Article 9 of Directive 2003/94/EC
• UK implementing directive: The Medicines for Human Use (Clinical Trials) Regulations 2004

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement. Records should also be kept for reference and to demonstrate compliance with GCP.

Minimum period

Retain for 30 years.

Provenance

European Commission: Guidelines on Good Clinical Practice (GCP) specific for Advanced Therapy Medicinal Products (ATMP)

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference.

Minimum period

Retain for 5 years after end of the trial.

Provenance

The sponsor of the trial is responsible under current legislation for keeping trial records. All clinical trial records should be retained for a longer (up to 30 years for ATMPs or paediatrics) if required by the applicable regulatory requirement(s) or if needed by the Sponsor as per Annex 1 to Directive 2001/83/EC and GCP requirements EMA/CHMP/ICH/135/1995.

The provisions of Directive 2001/83/EC are brought into UK law by the Human Medicines Regulations 2012.The HMR 2012 do not, however, reproduce the detail of the 2001 directive, so the original directive text should be referred to.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep to demonstrate compliance with GMP and evidence against future claims.

Minimum period

Retain for 5 years after end of the trial.

Comment

This is referring to manufacture under a Specials Licence for a metabolic study, hence the product is not an IMP.

Provenance

• Article 17 of Directive 2005/28/EC for Clinical trials, otherwise good practice.
• UK implementing directive: The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006