Analysis of Study Site Files

¶ … maintain complete and current study site files? Provide examples of how this documentation benefits the study and explain how it does so. The lack of adequate, accurate and reliable source of documentation is a common finding in an investigator site inspection. It is also a commonly identified pitfall in the course of the sponsoring audits. The significance of the practice of good documentation demands emphasis on the investigator sites and towards the surety that the results of the study are a basis for the validity and credibility of the data.

At a single site in question, recently, the source documents of an investigator site were unavailable due to the fact that the source machine containing the information had 'crashed'. Therefore, the evaluation of the record's adequacy was altered when availability was not a factor. The failure warning was therefore directed towards the investigator as the records to be maintained could not be retained for the required regulatory timeframe (Bargaje, 2011). The confirmation of the eligibility criteria is done by the tool of the given subject in trial.

Documentation is on the subject's progress; from its consent to the completion of the study. It keeps a record that accounts for how the investigational product is returned, consumed, and/or dispensed by the subject. It is referenced to the treating physician as the subject's completion of a medical record and also serves as a future reference. Finally, it creates a strong basis in the transcription of data into a Case Report Form (CRF) to its ultimate translation into a clinical study report.

Precise and correct documentation supports the fundamental principles that protect the subject's well-being, safety, and rights. An emphasis on the need for quality and reliable of documentation cannot be on two separate grounds (Bargaje, 2011).

Why is "Statement of the Investigator, Form 1572," an essential study file document? The investigator's statement, Form FDA 1572 (1 572), is a signed agreement partaken by the investigator towards the provision of giving specific information to the sponsor and a surety of a compliance by he/she in accordance to the FDA regulations in relation to the clinical investigative conduct of a biologic or an investigative drug (U.S.

Food and Drug Administration, 2008).The 1572 serves two roles: 1) the provision of information to the sponsor that is in relation to the qualifications of the investigator and the clinical site that will assist the same sponsor to document and establish that the location of the site is appropriate and that the qualifications of the investigator are approved in order to conduct the study, and; 2) to ensure that the investigator is well informed of his/her obligations towards the attainment of his/her commitment to follow the pertinent regulations of the FDA (U.S.

Food and Drug Administration, 2008). What are the legal obligations of Form 1572? Who is ultimately held accountable for the form's content and what are the specifics of this accountability? The accuracy of the form completion by the investigators should be as effective as possible. The investigators should be aware that the production of a willfully false statement is an offensive crime under the 18 U.S.C. 1001.

The 1572 obtained by the sponsor must be signed and complete prior to an investigator's permit to sanction his/her participation in the clinical study (21 CFR 3-12.53(c)). Having sufficient information concerning the study implies that the investigator has acquired copies, read and understood the investigator's booklet and the protocols of the study; plus he is also accustomed with the rules concerning the handling and management of clinical studies.

The signature of the investigator on the form constitutes an affirmation that asserts that the investigator is committed to abiding by the regulations of the FDA in the study's conduct. The requirement of the regulations is that.