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Clinical Research Organization - Roles And Responsibilities

Clinical research CRC is a person who is a specialized research professional, who will be working with or under the direction of a principal investigator (PI). A CRC will give whole support, promote and coordinate the daily clinical trial activity while playing a critical role in the conduct of study according to the protocol, ICH-GCP principals and other regulatory requirements. He has to work with the PI, the concerned department and the sponsor in order to provide guidance on the related aspects of the clinical study. For reporting he/ she have to report to the principal investigator, with associated responsibilities to the department head, division or program administrator.

Each and every clinical trial site may have one or more study CRC depending on the work load at the trial site. Role of CRC starts before to the conduct of clinical trial to after the close of the trial.

Role of CRC before the start of clinical trial:

Before start of a clinical trial, a CRC is prescribed to do all the ground works (like ...), which helps them to conduct the trail. He/she has to collect and complete the feasibility questionnaires received from different clinical research organizations, sponsors and principal investigator

Now sponsor will select the site base on the feasibility questionnaires and conduct pre site selection visits to conform the site which is participating in the study. Sponsors will conduct the investigators meeting, which are attended by the principal investigator, co-investigator and study CRC; these meetings will either be at a national or international level.

All the documents will be submitted with local ethical committee which include study protocol, investigator brochure, informed consent form with vernacular languages, investigators curriculum vitae, financial disclosure forms, insurance statements, indemnification letter (indemnity is a letter that is designed to protect a party to a contract from losses), different study logs, and CRF / eCRF entry guidelines including blank CRF's are to be submitted.

CRC should have good knowledge on study protocol, before to the start of the trial, must be well aware of all the Inclusion and Exclusion criteria. During the screening time the CRC should obtain the informed consent, previous medical records and has to conduct subjects scheduled visits. But before randomization visit of the subjects, he has to check the inclusion and exclusion criteria thoroughly and only eligible subjects should be enrolled in to the study.

All the visit details like Demographic, Vital signs, Subject Medical History, any serious adverse event or adverse event has to be entered in to the data collection tool like EDC oracle clinical remote data capture, medi data rave etc. During monitoring sponsors representatives like clinical research associates will cross check both the source documents and the data filled by the CRC. It will be the responsibility of the study CRC to keep all these documents up to date. Whenever subjects come for next scheduled visit, study drug accountability has to be calculated by the CRC. If study requirement needs the subject visit records IVRS (Interactive voice response system) and IWRS (Interactive web response system) need to be used.

In any cases of adverse event and serious adverse event that occurs during the trial, CRC has to collect all the details like Start date, stop date, severity (Mild, Moderate, Severe), Concomitant medications if any and route of administration. And he/ she has to collect information about the dechallenge and rechallenge therapy undergone by the subject during the SAE, and if any recovery details, whether it is related to study drug or not. This SAE has to be notified to the sponsor within 24 hours and to the ethical committee within 7 working days.

Role of CRC after the clinical trial:

CRCs are responsible for screening and recruiting participants, ensuring informed consent, collecting and recording data and participant follow-up. In addition, CRCs have a critical role in protecting human subjects in clinical trials.

Before a clinical trial is completed at the sites, the study CRC has to check and update all the necessary documents. On the day of close out, the CRA will verify all the documents, and further assist in archiving the documents at the site, because the site has to maintain all the study related records for 15 - 20 Years.

Thus the involvement of CRCs results in progress and improved quality of clinical trials.

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