BUREAU OF DRUGS 7. 8. GUIDE (5) Results of statistical consultation. If none was obtained, indicate at what point in the overall investigation a statistical consultation would be most appropriate. Summary Statements Regarding the Adequacy of the Protocol All six should be included. Any may be elaborated on as indicated. a. b. C. d. e. f. The risks of the proposed study (are/are not) acceptable in view of its objectives. The risks (are/are not) adequately appreciated. Adequate precautions (are/are not) being taken. Patients (are/are not) adequately informed through the informed consent form. (Note that the regulations do not require the investigator or sponsor to submit an informed consent form. If the reviewing division had a particular concern about a drug for safety reasons, then copy of the consent form should be requested). The study objectives (are/are not) clear and (are/are not) based on a sound rationale. The study protocol (is/is not) adequate to provide Recommended Regulatory Action. One of the following included. should be Any may be elaborated on if the M.0. so desires. In those cases in which other than a standard regulatory action is recommended the rationale should be presented: Study may proceed but would suggest considering the modifications suggested in the deficiency list. Study may not proceed until the action taken to correct deficiencies reviewed by the Agency. e. succeeded. Study may not proceed because repeated attempts to demonstrate от но. BD 80-23 (8/14/80) PAGE 6 GUIDE BD 4831.1 ATTACHMENT A BUREAU OF DRUGS f. Study may not proceed because the serious potential toxicity of the drug outweighs any possible benefit. 9. Deficiency/Problem List. A listing of deficiencies or problems in the submitted protocol or in the IND itself. They may indicate a need for required changes in, or additions to, the protocol or for additional studies, clinical or pre-clinical, that must be carried out. On the other hand, problems/deficiencies may lead to suggestions for modifications in the protocol or the IND that do not represent requirements, at least at the present time. Deficiencies/problems should be clearly, concisely stated and a. This is a suggestion for improving the study but not This is a deficiency that must be corrected before an NDA can the a be This is a deficiency that must be corrected before Phase III studies are started. от но. d. This is a deficiency that must be be corrected before Phase II e. f. This is a deficiency that should be corrected before Phase I studies are started. This is a deficiency that should be corrected during the present study if possible but the study may proceed. h. during the present be terminated (or, etc.). the proposed This is a deficiency that must be corrected before the BD 80-23 (8714/80) the FACE 7 10. IND Review of a Completed Study. This review would begin with a description of the protocol and the study objective (similar to the Resume of the protocol review above). The study would then be reviewed as outlined under the NDA Medical Review Guideline, Section 5 a (4) (a) (b) (c) and (d) and 5 b. GT NO. BD 80-23 (8/14/80) PAGE 8 |