Summary
Highlights
The video introduces Monica Quitiva, Director of the CRC Academy, who will explain how to create source documents. This serves as a preview of what's taught in the academy, but is comprehensive for those only interested in source document creation.
The most crucial step is to read the study protocol meticulously, especially the schedule of assessments and its footnotes. Footnotes provide vital details, such as the order of assessments (e.g., triplicate EKGs during screening vs. single EKGs later), specific times for vital sign measurements (e.g., supination for 5 minutes, sitting for 3 minutes, standing for 1 minute), and other critical instructions often overlooked.
The EDC system is another essential tool. If direct access is unavailable, screenshots from the monitor can provide formats and specific data requirements. The EDC indicates the information to collect per visit, including data formats (e.g., date formats, units for measurements like pounds vs. kilograms, temperature types and units). This ensures consistency and prevents overlooking small but important details.
Monica shares several tips: using Microsoft Word for creation, remembering that each state may have different regulations (e.g., California Bill of Rights), never assuming anything but always asking the monitor for clarification, and never leaving any fields empty. Following ALCOA-C principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete) is critical for FDA compliance, as empty fields are assumed not to have been done.
Source documents should include reminders for patients, such as dietary restrictions (e.g., no grapefruit), to ensure patient safety. They should also have sections for who completed the documentation (name, initials, date/signature) to ensure traceability. Specific instructions from the protocol, like how to measure blood pressure, should be integrated directly into the source document for easy reference during visits.
Creating a screening visit source document can take approximately four hours. However, this process forces coordinators to thoroughly learn the protocol, which is a significant benefit. Source documents only need to be created once per study and updated if amendments occur.
Progress notes must be written for every visit, even if brief, and multiple individuals can sign and date their entries. For screening and randomization visits, inclusion/exclusion criteria from the protocol should be copied and pasted into the source document, with 'yes/no/not applicable' options for verification, ensuring subjects meet study requirements.