Clinical Documentation In The Medical Trials

However advanced the medical trial is the documentation of the trial occupies the key place. The medical trials run for the longer period time and documentation details the key information regarding each and every stage of the clinical trial progress to present it for the approval. The documentation process however varies from project to project, the key details of the project remains the same. The collected data should be attested for authenticity and its use in the medical trial. This is quite helpful even for the researchers to re examine the proceedings of the clinical trial before they conclude the outcome of the clinical trial. The document can also be held for long term reference. 

The rules and regulations of the FDA have to be strictly adhered in the documentation process. few include labeling all the documents with the date, proper order of the documents, rules of the regulating authorities should be adhered to avoid discrepancies. The data enclosed in the document should meet the quality standards. The key documents of any clinical trial include case record forms, informed consent forms, protocol, investigators brochure and the patient information sheet.