The code of Federal Regulation (CFR) in Clinical Trials

Title 21 of the Code of Federal Regulations (CFR) pertains to food and drugs.

Chapter 1 of this guideline pertains to those components that identify the Food and Drug Administrations (FDA) and Department of Health and Human Services (DHHS). Within this set of regulations, Part 11, perhaps the most well-known and referenced section, specifically identifies the electronics records and electronic signatures It is important to note that any requirement under Title 21 in general are often referred to as "Predicted Rules" (refer)

These rules can be very helpful to determine that when part 11 rules apply to a specific situations, as well as how any aspect of clinical trial is performed..

On the subject of Good Clinical Practice, 21 CFR 50 , Deals with "Protection of Human Subject", is one such predicted rule that requires clinical trial subjects to provide written informed consent to participate in research trial.

More indirectly, Part 21 CFR 820.70(I) addresses automated process: 'When Computer or Automated data processing system used as a part of production or quality system, Manufacturer shall validate computer software for its intended use according to established protocol'.

While this regulation applies directly to manufacturing, it is the predicted rule that is cited as the reason that SAS Programs needs to be validated. There are numerous topics within Title 21 tat directly or indirectly affect programming.

Though you don't need to read each of these, it is helpful to understand what parts of Clinical Trial and programming process are driven by these rules.

Part 11 of this code contains several sections. each sections outlines the steps to take to ensure that the electronic records, electronic signature and hand written signatures that are applied to electronics clinical data are truthful, dependable and equal to paper records and hand written signatures on papers.

Most important to SAS Programmer is the section that dictates how records can be modified : "Use of secure, computer generated time-stamped audit trials to independently record the date and time of operator entries and actions that creates, modify or delete electronics records. Record changes shall not obscure previously recorded informations". The key principle of this regulation is to understand that "data cannot just be changed, but a specific procedure must be followed".

This regulation is the main reason why Clinical SAS Programmer are not permitted to hard code data changes.

for more information refer to following links



CFR Part 11

FDA Predicted Rules

Ref: Validating Clinical Trial Data Reporting with SAS.