When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.

The sponsor should update the Investigator's Brochure as significant new information becomes available.

The characters of the investigational product(s), including active comparator(s) and placebo should be appropriate to the stage of development of the product(s).The manufacturing, handling and storage of the investigational product(s) shall comply with the GMP. The labeling and codes should protect the blinding design.

The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions, storage times, reconstitution fluids and procedures, and devices for product infusion, and should inform monitors, investigators, pharmacists, storage managers and any other involved parties.

The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage.

In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.

If significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development, studies about whether the new formulated product(s) significantly alter the stability, dissolution rate, bioavailability and other pharmacokinetic profile of the product(s) should be completed prior to the use of the new formulation in clinical trials.

The sponsor should not supply an investigator and an institution with the investigational product(s) before the trial is approved.

The sponsor should ensure that written procedures include:
1.The instructions that the investigator and the institution should follow for the handling and storage of investigational product(s).
2.Procedures about handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor.

In the aspect of the handling of investigational product(s), the sponsor should:
1.Ensure timely delivery of investigational product(s) to the investigator(s).
2.Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s).
3.Follow and maintain a system for retrieving investigational products and documenting this retrieval.
4.Follow and maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition.
5.Ensure that the investigational product(s) are stable over the period of use.
6.Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications if necessary.
7.Maintain records of batch sample analyses and characteristics.
For samples referred to in item 6 and item 7 for extending storage permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.

The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).