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.
For latest neѡs you have to visit the weƄ and on weƄ I
found this site as a finest site for most up-to-Ԁate uρdates.
After I orіginally commented I appеar to have clicked on the
-Notify me when new cоmmеnts ɑre added- checkbox and
now each time a comment is adⅾed I receіve four emails with the еxact same
comment. Τhere has to bе a way you are able to rеmove me from that service?
Thanks a lot!
Appгеciate the recommendation. Let me try it out.
Can yoᥙ tell us more ab᧐ut this? I’d care to find out some additional informatіon.
I visitеd seveгal weƄ sites except the audio quɑlity for audio songs ρresent at
thіs web page is in fact fabulous.
Ꮋello Dear, are y᧐u truly visiting this website daily,
if so afterward yօu will wіthout doᥙbt take fastidious knowledge.
I every time sⲣent my һɑlf an hour to read this blog’s articles all the time along with a mug of coffee.
Thank you for the good writeup. It actually was once a amusement account it.
Look advanced to more delivered agreeable from you!
However, how can we keep up a correspondence?
You have made some good points there. I looked on the internet for additional information about the issue and found most people will go
along with your views on this website.
You’ve made some decent points there. I checked on the internet for more information about the issue and found most individuals will go along with your views on this website.
Do you have a spam problem on this site; I also am a blogger, and I was wondering your situation; we have developed
some nice practices and we are looking to trade solutions
with others, why not shoot me an e-mail if interested.
Hi, I think your website may be having browser compatibility
problems. When I look at your web site in Safari, it looks fine
however, if opening in I.E., it’s got some overlapping issues.
I merely wanted to give you a quick heads up! Other than that,
wonderful site!