A clinical research coordinator (CRC) is responsible for conducting clinical trials at clinical trial sites according to the protocol, ICH-GCP and other regulatory requirements. The role of a study coordinator in clinical trials is very important. Every clinical trial site may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. Let us discuss about the role of the study coordinator in these three stages. The three stages are:
1) Before the start of the clinical trial
2) During the conduct of the clinical trial
3) After close out of the clinical trial
1) Before the start of the Clinical Trial:
During this stage the study coordinator has to collect and complete feasibility questionnaires received form different CRO’s and Sponsor’s. CRC’s also have to collect required information from the principal investigator, and send it back to the respective people who contacted the site regarding the study. Sponsors select sites based on the responses filled in the feasibility questionnaire and conduct Pre-site selection visits to confirm the sites participating in the study.
The sponsors or CRO’s after selecting clinical trial sites conduct Investigator meetings, which have to be attended by the study coordinator along with the principal or co-investigator. Investigator meetings are conducted either at national level or international level. Before start of the trial CRC’s are usually busy with submitting all study documents to the ethics committee. Documents to be submitted to the ethics committee normally include the study protocol, investigator brochure and informed consent forms (vernacular languages at site) with translation certificates. If any amendments are available those also need to be submitted to the ethics committee. In addition to these documents, investigator’s CV with MRC, FDA-1572, Financial disclosure forms, Insurance statement, subject diaries if applicable, clinical trial agreement, indemnification letter, protocol signature page and different study logs, eCRF or CRF entry guidelines, blank CRF’s etc also need to be submitted.
In all these processes a clinical study coordinator plays a vital role. After obtaining approval from the ethics committee the clinical trial can be initiated at the site level.
2) During the conduct of clinical trial:
By the time a clinical trial is initiated at a site the CRC must have a good understanding of the study protocol and must know well about inclusion and exclusion criteria. During the screening time, the study coordinator has to obtain informed consent from the subject in if delegated to do so by the Principal Investigator. Study coordinators have to collect subjects previous medical records and according to study protocol he/she has to conduct subjects scheduled visits. Before randomization visit of the subject the CRC must check inclusion and exclusion criteria thoroughly, and only then eligible subjects must be enrolled into the study.
After completion of all visit procedures coordinators have to enter data in case report forms (CRF). CRF’s are two types, one is paper CRF and another one is eCRF. eCRF’s are usually of 5 types namely , Phase forward – Inform, oracle clinical remote data capture, medi data rave, novartis EDC (or) Pasco and Data track. All the visit details like demographics, vital signs, subject past medical history, any SAE or AE details have to be entered in these online data collection tools based on source documentation available. During monitoring, sponsor representatives (CRA’s) cross verify both the source documents & the data filled by the CRC in the case report forms. During the monitoring visit the CRA’s also verify EC notifications and Investigator Site Files (ISF). To keep all these documents up to date is the responsibility of the clinical study coordinator. Study coordinator also has to maintain site SOP’s, EC sops and EC members list.
Whenever study subjects come for next schedule visit, study drug accountability has to be calculated by the CRC. Along with that subject diaries have to be reviewed if applicable. IVRS (Interactive voice response system) and IWRS (Interactive web response system) to record the subject visit have to be performed as per the study requirement. IVRS reports have to be maintained in the ISF’s. IP (Investigational product) is the major part in clinical trial and study coordinators have to store the same in proper condition and maintain required temperature logs.
In case of any adverse events (AE’s) or serious adverse events (SAE’s) that occurred at the trial site, coordinators have to collect all applicable details such as start date, stop date, severity (Mild, Moderate or Severe), concomitant medications consumed by the subject and the route of administration. Also information related to any dechallenge and rechallenge, therapy provided to the subject during the SAE, recovery details and whether it is related to study drug or not have to be collected. Study Coordinators have to notify SAE’s to the Ethics committee within 7 working days and details of SAE have to sent to the sponsor within 24 hours.
Throughout the clinical trial the study coordinators have to check all Central lab reports as well as local lab reports and take PI signatures on them to document that the PI reviewed the lab reports. CRC is also responsible for telephonic reminders to the subjects regarding the visits. If the CRC is involved in data entry then it is the study coordinators responsibility to resolve all queries within 48 hours or as per timeline specified by the sponsor. Queries are of three types i.e. 1) system generated queries 2) data management generated queries and 3) CRA generated queries.
3) After Close out of clinical trial:
Before a clinical trial is closed at the site, study coordinators have to check all documents and all the documents have to be updated. On the day of close out CRA will verify all documents. After verification of all documents by the CRA, CRC will assist in archiving the documents at site. Site has to maintain all study related records for 15 to 20 years.
As you can see a CRC plays a vital role in managing a clinical trial at the site level and acts as a link between the sponsor, EC and the Investigator Site.