Clinical Protocols adverse experiences

It is very important to keep in mind that approximately 80% of drugs studied never reach the marketplace. Many of these drugs are discontinued because of toxicity. Therefore, in the selection of investigators to conduct a clinical study, it is very important that they be committed to conducting the study in accordance with the relevant protocol and that they personally supervise the investigation and report all adverse experiences that occur. 

Provision should be made to communicate any changes to a study plan or protocol, and all serious adverse experiences, to all investigators involved in the trial in a timely fashion. These changes must also be reported to their respective institutional review boards. Additions, changes, or corrections to clinical data should be made only by the investigator, or individuals authorized by the investigator, and must be carefully documented. 

Protocols [ 312.23(a)(6)], protocol amendments [ 312.30], previous human experience [ 312.23(a)(9)], safety reports [ 312.32] and informational amendments related specifically to clinical [ 312.31] including adverse reactions, consent forms, investigator information, general investigational plan, Investigator s Brochures, IRB approval, new protocols, revised protocols, site information, investigator data, CVs, and 1572s... 

The regulatory procedure involved is a so-called Clinical Trial Authorization appH-cation (CTA) and consists, in addition to a Clinical Trial Protocol (CTP) and Investigator s Brochure (IB), of an Investigational Medicinal Product Dossier (IMPD) in CTD format. The IMPD consists of quality data, nonclinical pharmacology and toxicology data, clinical trial and previous human experience data, and an overall risk-benefit assessment. A copy of the CTA is sent to each EU Member State where the study is conducted, as well as to the Ethics Committees for approval. These also have to be notified in case of any amendments, study termination and adverse reactions. The contents of the IMPD are case specific and may be simplified or even replaced by the... 

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