Drug Evaluation Committee 2013-59 Start Date for Provision of Investigational New Drug Safety Information
Related classification: Adverse drug reaction reports
Date of first publication: Apr. 2014
Question
Reporting of safety information by the sponsor to the investigator occurs from which of the following dates? I was told by one sponsor that it would occur from the date of agreement of the study protocol between the investigator and the sponsor.
- 1.The date of agreement of the clinical trial.
- 2.Date of request for clinical trial.
- 3.Date of clinical trial agreement
Pharmaceutical Cooperative Opinion
The purpose of providing safety information is slightly different before and after the conclusion of the contract. The purpose of providing safety information before the conclusion of a contract is to provide the person who is to become the principal investigator with the information necessary to agree on the clinical trial protocol and to provide the information necessary to prepare explanatory documents for subjects (GCP Article 7, Paragraph 4/5, Guidance 1, Article 9, Guidance 1).
However, GCP does not stipulate the timing of provision of safety information prior to the conclusion of a contract, so it does not matter whether the starting point is the date of agreement or the date of request, as long as the purpose of provision is achieved. We recommend that each sponsor confirms the timing of provision of safety information on an individual basis, as there may be some differences.