Clinical Research Documentation Compliance
Clinical Research Documentation Compliance is done in two forms, in hard copy, as well as electronic capture or Case Report Forms. Hard copy of clinical research documentation should always be maintained. Each event must be recorded in order to confirm the study as it is a saying in clinical research, “ Anything that is not documented has not been done”.
Clinical Research Documentation Compliance is the most important aspect of Good Clinical Practices. In order to comply with the guidelines of regulatory agencies, clinical research documentation compliance is mandatory.
Legal Mandate for Clinical Research Documentation Compliance:
Legally, proper documentation by clinical research organization in India is a part of the physician's profession. Patient records ensure meaningful information at a time when the patient decides to switch to another professional for treatment.
Documentation purpose for Clinical Research Organizations:
- To record patient's clinical course.
- To record how the study was done and who were the team members.
- To record the minutest details of the patient including the change of dosage and the patient's reaction on it. This proves beneficial for the patient in case the patient changes treatment or the physician.
- Documentation of Informed Consent, and problems encountered while treatment prevent malpractice.
- Documentation also helps in risk management.
- To comply with the regulatory requirements and legal safety.
- To assure quality. The records contain services provided, and effectiveness of treatment. This helps the medical staff to overcome the shortcomings and prevents the mistakes from repetition.
- To ensure coordination among the team members. The documentation ensures every aspect of the treatment is recorder and which can be viewed by all. This ensures coordination.
Good Clinical Documentation Practices- Features of a Good Clinical document following the Clinical Trials compliance line include:
- Use of present tense.
- Use of quotes from patients.
- It should reflect professional knowledge and judgment.
- It should include proper headings and logics.
- It should clearly define facts, observations, and opinions.
- It should present relevant and detailed information.
Electronic Documentation:
Electronic capture of the Case Report Forms (CRFs) has to be in compliance with 21CFR part 11. This is a Code of Federal Regulations is a multivolume set, divided into 50 titles representing broad areas of federal regulations. Each title deals with different areas of work. Title 21 is concerned with Drugs and cosmetics. 21 CFR part 11 deals with electronic submissions. 21 CFR pertains to:
- Ensuring authentication of the data.
- Authenticity of signatures.
All the softwares designed for the data capture and management have to be designed in accordance to the rules of 21 CFR part11, the violations of which may lead to deviation from clinical research regulatory documentation compliance and may invite a penalty.
