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Clinical Research Document Control

posted Feb 19, 2013, 2:20 PM by Jeremy Wilkerson   [ updated Mar 8, 2013, 1:03 PM ]
Continuing on with our second Standard Operating Procedure (SOP) within the general and administrative SOPs is the SOP on Document Control. This SOP outlines the process for controlling and distributing controlled documents within your site in order to ensure that the most current versions of each document is being used. 
The documents that specify or prescribe quality requirements or activities affecting quality are controlled to ensure that the correct documents are being employed. It is important to have control over all documents, including:
· Identification Control
· Distribution Control
· Change Control
· Review and Approval Control
· Version Control
As discussed last week, all documents have identifying numbers including document type, department identification, and the document number. All documents, when revised, edited, or rewritten must receive approval from the approving party. Once approved, the most current SOP replaces all old versions. Document control and document identification help to ensure a smooth revision, review, and approval process. 
OV Clinical Research’s site-specific SOPs are customizable, comprehensive, GCP/ICH Compliant, Industry Standard, and instantly downloadable. Our Clinical Research SOPs have already been implemented by Clinical Investigators and Clinical Research Coordinators in multiple countries across multiple continents. These SOPs have been written by a multi-disciplinary team with significant regulatory and clinical experience with FDA, Sponsor Companies, CROs and the Investigator Site. Clinical Trials Standard Operating Procedures are intended to support compliance with regulations, and guidance that govern the conduct of clinical research. These clinical trials research SOPs establish standards for those responsibilities that regulatory authorities have attributed to the Investigative Site or Sponsor. Well-written and well-managed GCP SOPs provide an official way to consistently execute required research-related activities. In addition, they can improve communication among staff, reduce dependence on individuals with institutional knowledge, and improve efficiency of staff training. SOPs that establish standards of practice for how you will meet these responsibilities that will help your company demonstrate to auditors and/or inspectors that you are aware of the regulations and guidance and have built the foundations of a good quality system for clinical trials. To increase quality, it is imperative to keep up to date with industry standard information pertaining specifically to sites. OV Clinical Hub automatically sends out yearly updates to keep your Standard Operating Procedures current.