Drug Evaluation Committee 2011-21 Preparation of Source Documents by CRC dispatched by SMO
Related classification: Principal investigators, subinvestigators, etc.
First published: Sep. 2011
Question
Is it acceptable for an SMO CRC to write the worksheet? Recently, we have been told to be aware of ALCOA when preparing source documents; is it correct to assume that the SMO CRC's records and notes are also considered source documents?
Background of the question
Currently, there are mixed opinions among SMO CRC regarding the inclusion of information on worksheets that do not involve medical judgment, such as vital signs and blood collection times, as follows.
- No, they should not be filled out.
- The CRC prepares it on a computer or stamps it and gets the physician to sign or stamp it
- CRC fills in the form and gets the physician to sign or stamp it
- CRC fills out the form
Since each sponsor seems to have a different view, it is common practice to confirm in advance whether or not to fill in not only the worksheet but also other source documents such as faxes for case registration that could be used as source documents. In the first place, why was the idea that SMO CRCs were not allowed to fill out the form, not just because they are outsiders, and what regulations, if any, were the basis for this?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
(1) Is there a problem with the SMO CRC describing the worksheet?
According to the "Report of the Study Group for Establishing Standard Guidelines for the Use of SMOs "*, workers dispatched by an SMO may not perform tasks that assist in medical practice or treatment, but they may perform administrative support and assistance in the provision of medical care. The entry on worksheets of matters that do not involve medical judgment in the provision of medical care is considered to be clerical support/assistive work related to the provision of medical care under the direction of the investigator, etc., and is therefore not considered to be a problem. However, in principle, the person who observed and measured the (original) data should prepare the records (source documents), so the contents of the source documents prepared by the SMO CRC should be confirmed by the person responsible for the relevant work (investigator, etc.), and this should be clear in the records.
(2) Are the SMO CRC's records and notes also source documents?
Records and memos created by the SMO CRC can also be considered source documents if they are identified as such by the investigator, but in this case, they must be retained as documents belonging to the site for the period specified in the GCP. We recommend consulting with the investigator in advance about the items and contents of data to be collected at the start of the clinical trial, including how to keep records and how to confirm the contents.
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As of December 2023
Report of the Study Group to Establish Standard Guidelines for the Use of SMOs" (November 2002, Ministry of Health, Labour and Welfare)
(Excerpt)
"Among services related to the conduct of clinical trials and management of investigational drugs, services related to assisting medical practice and treatment and services related to dispensing drugs performed by pharmacists are not allowed to be outsourced or dispatched as workers, and SMOs are not allowed to perform such services under contract or by worker dispatch. It is considered that SMOs cannot be commissioned or dispatched to perform such services. However, it is considered possible for SMOs to perform clerical support and assistance services related to the provision of medical care through worker dispatch.