How to Understand Clinical Records Management

Clinial records management

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By Sarah Wilson CCRP
eHow Community Member

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When conducting clinical trials, clinical records management applies to the sponsor and the clinical investigator. The sponsor is responsible for maintaining at least 26 categories of records as identified by Good Clinical Practices. The clinical investigator is responsible for patients’ medical records, history and private information. Both entities must adhere to specific rules identified in Health Insurance and Portability Act (HIPAA) and Good Clinical Practices. Read further to better understand clinical records management.

Difficulty: Moderately Easy

Instructions

Things You'll Need:

Basic knowledge of clinical research

Step 1

The Clinical Investigator and Clinical Records Management.

The clinical investigator, usually a physician or scientifically qualified person with patients, have access to a person’s most personal and intimate information. Some of this data is in “loose paper” format, some in electronic “database” format and some are in both formats (hybrid) as the industry attempt at becoming paperless proceeds. Regardless of the format, the content of these records MUST be protected.
Step 2

Clinical Records Management and the Sponsor.

Sponsors should not have the names of the people volunteering for their clinical trials. The sponsor have laboratory results, birth dates, geographical information, physical exam results and other protocol required data; however, it should not be in a format that allows it to be linked to any individual. The clinical records sponsors have to manage are clinical records showing how the clinical trial was conducted. These records are collectively referred to as an “audit trail” and include proof of an investigators qualification (e.g. medical license, resume, etc.), proof of ethics committee review and approval of clinical trial protocol and Informed consent document, etc.
Step 3

Learn What Applies to You.

A clinical investigator site can find out more about protecting patient rights by reviewing the HIPAA rules. A sponsor can find the documents required by GCPs by reviewing ICH Guidelines for Industry (ICH E6) Good Clinical Practices Section 8 titled “Essential Documents for the Conduct of a Clinical Trial”. This section will tell you the documents required before the clinical trial can start, the documents required while the clinical study is ongoing and when it ends. It will also explain what is required to be maintained at the clinical investigator site, the sponsor’ s facility or both.
Step 4

Managing Electronic Clinical Records.

Even though you do not hear a lot about 21 CFR Part 11 (Electronic Records and Electronic signatures), researchers should be aware that the FDA has the option of inspecting your records for compliance with that regulation. At a minimum, they will probably want to assess the security of the electronic records. There are a lot of software available to help you implement your electronic clinical records management system. Once you have the software, complete the validation. At a minimum, the FDA may want to know 1)Who have access? 2) How is it accessed? 3) If password protected, how often are the passwords changed? and 4)Are the files backed-up and retrievable when needed? Ensure your electronic clinical records management system is validated and proper safety measures are functioning as expected.
Step 5

Check out the resource section for additional information that will help you understand clinical records management.

Comments

rjs0714 said

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on 8/25/2008 great article - i only wish I had written it! lol!

luv2blog said

on 8/21/2008 Thanks TK and smiles@me: I got a PM asking me to write on this topic. I hope I answered that visitor's questions. I guess I'll find out soon enough!