Drug development protocol changes

The corporation must have an SOP that combines the method development and validation activities. Also, SOPs for the preparation of analytical method and validation protocols must stress change control and procedural deviations. The SOPs must allow the analytical chemist to revise methods and protocols to reflect changes encountered during the drug development process. Additionally, an accurate audit trail of changes must exist to track all changes and modifications. 

It is possible to switch kit reagents or change assay conditions if this suits the specific requirements of the study. Assay conditions, for example, incubation times, can be changed from the method supplied in the kit protocol to suit the drug development program. 

The Sponsor Discontinuation section of the protocol provides a reminder to the investigator that the trial may be terminated prematurely as a result of a regulatory authority decision, a change in opinion of the IRB/IEC, drug safety problems or at the discretion of the sponsor. In addition, most sponsors will reserve the right to discontinue development of the investigational product at any time. 

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