Clinical trials report regulatory submissions

The submission must be formatted in a manner that is consistent with the requirements of the regulatory agency that will review the submission. The dossier may include 20 or more individual clinical trial reports. They should be uniform in format to assist the reader to assimilate evidence readily and to compare it between trials. The whole dossier should be one of accuracy, consistency and meticulous cross-referencing. Once again, the effort to reach these objectives must be made in the early planning stages. 

Examples of product quality GxP data include study data (e.g., stability trial data, clinical trial data, patient and animal records/results), regulatory submissions (e.g., stability data, development summary reports), analytical production data (e.g., analytical methods, quality reference data), and compliance management (e.g., indexes to archived documents/records). 

In contrast to GLP regulations, GCP does not require an audit for all trial reports. The number of report audits may depend on the audit plan, the importance of the trial for a regulatory submission and the confidence in the procedures followed for evaluating clinical study data and writing reports, just to name a few. 

Before entering into a clinical evaluation program, a drug candidate is subjected to a number of preclinical studies to further define and characterize its safety profile. The results from the pharmacology, developability, and preclinical studies are documented in technical reports or scientific publications and used to prepare a regulatory agency submission for the initiation of human clinical trials. All of the preclinical studies,... 

It is very important to note that it is considered unethical to intentionally determine biocompatibility or biostability in human clinical trials. These parameters are to have been established before regulatory submission and the first human implant. Of course, should any untoward result be found clinically, or in prior preclinical tests, it must be reported according to FDA regulations. The clinical study is to determine the human safety and reliability of the new product, not its biocompatibility or biostability. The requirements for the development of clinical study plans can be found in the FDA Guidance [29]. 

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