As a CRA, I regularly visit the sites to review the study conduct, encourage study participant recruitment, evaluate the ongoing suitability of the investigative site, provide protocol specific training, track investigative supplies, and to review source documents. Source documents are the roadmap and clinical record to let me (or anyone who is reviewing) know what happened, when, how, and by whom. When I look through source documents I am checking that they follow the principle of ALCOA:
- A-attributable, who wrote this?
- L-legible, can I read this?
- C-contemporaneous, was this recorded at the time of trial conduct or later?
- O-original, is this unaltered or copied?
- A-accurate, is this a correct reflection of the conduct?
|It is never acceptable to use|
correction fluid in source documents.
Some sponsors actually provide source documents to the investigators to assist them to record all the required data during the study visits. The source templates will typically have a blank header to record the subject identifying information and to indicate the date of the visit. Quality source will also include signature or initial blocks on each page so that the person(s) completing the forms can be identified later. If source documents are complete and accurate, the clinical trial data can be copied over and provided to the sponsor on Case Report Forms for analysis. I'll provide an introduction to data capture/EDC and analysis in a future blog topic.
During source document review I always find items that are incomplete (left blank), inaccurate (such as blood pressures that are inconsistent with life, headers that indicate a different patient entirely, birth-dates that don't match the age, units or counts that aren't possible), or otherwise erroneous source. I use small colored post-it notes (stickies) to flag my findings and ask the PI or the study nurse to review and update the source with notation. I never "fix" the source myself. If the source errors are very wide in scope, I will note it in my monitoring report and I may also ask the investigator to generate a signed and dated Note to File on the site letterhead explaining what happened with the source documents and the corrections completed during our visit. Experienced study coordinators and investigators will not be surprised or frustrated when I request source corrections or clarifications. Also, discovering errors in the source does not upset me at all, this is part of my job and I am partnering with the site to help them keep their documentation totally complete and an accurate reflection of what was done.
|Source documents are created during the patient visit and should not be fabricated a few days before a monitoring visit.|
You may also like...from The Lead CRA archives: