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Good Documentation Practices in Clinical Research
Aug
If you step foot into the world of clinical research, the first thing you’ll learn is how important good documentation is. Practicing good documentation is necessary for proving the results of your research. You must record what you did as well as what you didn’t do. Additionally, these records must be accurate, credible, and accessible for anyone who becomes involved in the project. Good documentation practices in clinical research are an important part of the good clinical practice (GCP) guidelines put forth by the ICH. To ensure your research is reliable and lasting, make sure you pay attention to the following standards and guidelines.
The Importance of Source Documents and Data
Good documentation practices rely on source documents and the data within them. Source data and source documents, as defined by the ICH-GCP guidelines, are important terms for any clinical researcher to know. Source documents are the original documents, data, and records involved in the clinical trial. This might include hospital records, laboratory notes, subject evaluations, and other verifiable files that pertain to the research. Source documents can also include copies or transcripts of the original records as long as those copies are certified and accurate. Source data, on the other hand, is the information found in these original and certified source documents.
Attributes of Good Documentation Practices in Clinical Research
The United States Food and Drug Administration originally put forth five attributes of good documentation practices: attributable, legible, contemporaneous, original, and accurate. Over time, these criteria evolved into 11 attributes used by the FDA and the World Health Organization:
- Attributable – The data should clearly show who documented it.
- Legible – The data and any signatures should be readable.
- Contemporaneous – Researchers must document data alongside the flow of events or record chronology along with their observations. Researchers must define and justify any delays that occur in documentation.
- Original – Documents and data should be original or exact copies. Investigators should have original source documents.
- Accurate – Data must be an accurate, consistent, and real representation of the facts.
- Enduring – Information should be long-lasting and durable.
- Available and accessible – Documents and data should be available for researchers, physicians, and inspectors to review in a reasonable amount of time.
- Complete – Information should be complete up until that point in time.
- Consistent – Research should consistently demonstrate these attributes.
- Credible – Information should be based on real, reliable facts.
- Corroborated – Evidence should exist to back up all data.
The more a clinical research project meets these criteria, the more acceptable the data becomes. These attributes help establish integrity and excellence in new data. As you can see, having reliable documentation is crucial to creating credible conclusions. Make sure you buy laboratory notebooks that are sturdy enough to protect and present your research. When you can trust the journal you record in, you can maintain successful, reliable lab notes that will enhance your research and keep your project on track until you have the results you need.
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