Proper Documentation for Clinical Trials

¶ … regulatory requirements involved will be covered. The report will also include an answer to the question of what three of the file documentation requirements are before a study can be begin at a given site. While the rules and regulations regarding clinical trials may seem arduous and aggravating, they exist for a very good reason. As explained by the class PowerPoint, the role of the Investigator's Brochure is to offer a compilation of all clinical and non-clinical information that is relevant to a study.

It also serves as a reminder and review of the protocol that must be followed. That protocol includes the rationale for the study as well as the compliance that must be part of the study. For the sponsor in particular, the Investigator's Brochure serves several specific needs.

These needs include all information known an investigational drug, whether serious or adverse events are "expected" or "unexpected" during the trial, a summary of the reporting requirements that will kick in if/when an adverse event happens and a brochure that provides a framework for the USPI package insert for the drug in question (Investigator's Brochure, 2015). Basic content that is included in the brochure would include the name of the sponsor, the drug substance identifier (i.e. name, compound number, etc.) as well as the version number and date.

If the version is not the first iteration of a drug being tested, the prior versions should be listed and summarized. A table of contents should give a rough overview of the structure of the document. The first three sections should generally be a quick summary, a list of terms and their definitions and an overall introduction to the study and what is being sought after when it comes to the drug being tested.

Up next would generally be the properties of the drug (including physical, chemical and pharmaceutical properties or formulations) and any non-clinical study results that are useful including non-clinical pharmacology, pharmacokinetics and toxicology. Examples of the latter would include its propensity to cause cancer, harm to pregnant mothers and its tendency to mutate. Of course, the effects and safety factors regarding humans would be covered.

There would also be a summary of the data and guidance for the investigator as well as a listing of any relevant tables and figures that are relevant to the drug being tested.

Three additional documentation requirements that must be mandated or completed before a study can begin would include an investigator brochure or label for each principal investigator, the study must be sent to the internal review board (IRB) or institutional ethics committee (IEC) overseeing the study and there must be a plan to report any adverse events or deaths to the proper agencies just in case they do end up happening (PPD, 2015).

The final major part of a study and its documentation that will be covered is what is known as the informed consent documentation. This is the documentation that is presented to the study participants and the, obviously, is to make sure that they know the procedures, what the process will be and the risks involved before the study begins.