ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

(d)

In blinded trials, the sponsor should implement:

(i)

A process to blind individuals, including the sponsor staff, trial participant, investigator and/or investigator site staff, as appropriate, to the investigational product identity and assignment, and a process to prevent and detect inappropriate unblinding; A procedure and mechanism that permits the investigator to rapidly identify the product(s) in case of a medical emergency where unblinding is considered necessary, while protecting the identity of the treatment assignment of the other trial participants; A mechanism that protects the blinding of the trial where a participant’s tr eatment assignment is unblinded for the purpose of safety reporting to regulatory authorities and/or IRB/IEC, where appropriate.

(ii)

(iii)

(e) If significant formulation changes are made in the investigational product(s) (including active control(s) and placebo, if applicable) during the course of clinical development, the results of any additional studies of the formulated product(s) (e.g., stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the pharmacokinetic profile of the product should be available prior to the use of the new formulation in clinical trials. (a) The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational product(s). Where appropriate, the sponsor may supply the investigational product(s) to the trial participants in accordance with applicable regulatory requirements. Investigational product should be supplied after obtaining the required approval/favourable opinion from the IRB/IEC and the regulatory authority(ies) for the trial. Various approaches for shipping and dispensing may be undertaken, for example, by taking into consideration the characteristics of the investigational products, the route and complexity of administration and the level of existing knowledge about the investigational product’s sa fety profile. Investigational product management should be arranged and conducted in accordance with applicable regulatory requirements, and safeguards should be in place to ensure product integrity, product use per protocol and participant safety. (b) The sponsor should ensure that instructions are available for the investigator/institution or trial participants on the handling and storage of investigational product(s). The procedures should consider adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from participants and return of unused investigational product(s) to the sponsor (or alternative disposition if authorised by the sponsor and in compliance with the applicable regulatory requirement(s)). Supplying and Handling Investigational Product(s)

3.15.3

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