December 26, 2023
What is 21 CFR Part 11?
Title 21 Code of Federal Regulations governs Food and Drugs. Part 11 is the Food and Drug Administration (FDA) guidelines that sets forth the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health.
Code of Federal Regulations Title 21
•2003 - Part 11, Electronic Records; Electronic Signatures — Scope and Application
•2007 - Guidance for Industry Computerized Systems Used in Clinical Investigations
Additional Guidance:
2001 > General Principles of Software Validation
When do I need to be 21 CFR Part 11 Complaint?
According to FDA’s 2007 Guidance for Industry Computerized Systems Used in Clinical Investigations:
If you are conducting a clinical trial and using computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial.
- Applies to computerized systems that create source documents (electronic records) that satisfy the requirements in 21 CFR 312.62(b) and 812.140(b), such as case histories.
- Applies to recorded source data transmitted from automated instruments directly to a computerized system (e.g., data from a chemistry autoanalyser or a Holter monitor to a laboratory information system).
- Applies to when source documentation is created in hardcopy and later entered into a computerized system, recorded by direct entry into a computerized system, or automatically recorded by a computerized system (e.g., an ECG reading).
-Does not apply to paper records submitted electronically (scanned, faxed copies)
What are clinical trials?
Biomedical or health-related research studies in human beings that follow a pre-defined protocol. Register trials at: ClinicalTrails.Gov
What are the different types of clinical trials?
- Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
- Diagnostic trials: are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials: test the best way to detect certain diseases or health conditions.
- Quality of Life: trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
What are the phases of clinical trials?
The trials at each phase have a different purpose and help scientists answer different questions:
- In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.