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Click ‘Get Form’ to open the MON FORM 003 in the editor.
Begin by entering the study name and details of the monitor(s) and investigator. Ensure all names and titles are accurately filled in.
In the RECRUITMENT section, input anticipated enrollment dates and numbers. This helps track recruitment progress effectively.
Complete the INVESTIGATOR AND STAFF section by answering each question regarding qualifications, training, and experience. Attach relevant documents where necessary.
Proceed to FACILITY/OPERATIONS, ensuring that all facilities meet study requirements. Document any certifications or licenses as needed.
Fill out STUDY PATIENT POPULATION by discussing inclusion/exclusion criteria and access to required patient populations.
In REGULATORY COMPLIANCE/ADMINISTRATIVE PROCEDURES, list IRB details and ensure all necessary attachments are included for review.
Finally, review your entries for accuracy before saving or sharing the completed form directly from our platform.

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What is documentation in clinical research?

In clinical trials, there are two documents that stand between successful participant recruitment and regulatory approval: the Informed Consent Form (ICF) and the Participant Information Sheet (PIS).

What are the common source documents for clinical research data?

Source documentation is the medical record of the subject before, during and after the trial. It is the tool which confirms the eligibility criteria of the subject in the given trial. It documents the progress of the subject from consenting till the subject completes the study.

What are essential documents in clinical research?

Common source documents are participant medical records, phone encounters or notes, lab and diagnostic test results, participant diaries and specific research worksheets used to document key research data elements. If data are entered directly into a computer system, the electronic record is considered the source.

What documents are used in clinical research?

Key documents for clinical trials are also listed such as the investigators brochure, clinical study protocol, case report forms, informed consent forms, and clinical study reports.