(a) The sponsor should ensure that the investigational product(s) (including active control(s) and placebo, if applicable) is characterised as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s).
(b) The sponsor should determine acceptable storage temperatures, storage conditions (e.g., protection from light) and shelf life for the investigational product(s), appropriate reconstitution fluids and procedures, and devices for product administration, if any. The sponsor should inform all involved parties (e.g., monitors, investigators, pharmacists, storage managers) of these determinations.
(c) The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage.
(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;
(ii) 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;
(iii) A mechanism that protects the blinding of the trial where a participant’s treatment assignment is unblinded for the purpose of safety reporting to regulatory authorities and/or IRB/IEC, where appropriate.
(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.