CLINICAL TRIAL SITE MANAGEMENT
Clinical Trial Site Management will involve various activities and tasks which we have divided into different headings like;
- Site Visits – Site Initiation, Interim Monitoring, Data Cleaning, Site Close-out
- SAE Reporting received from site and to be reported to Sponsor and DCGI
We propose following types of site visits to be done.
Site initiation visit will be done once the project is approved by the Ethics Committee and the IPs are received by the site. The objective of this visit will be introduction with the Investigator team and the site training. Site training will be imparted to Investigator and his team that includes the co-investigators, study co-coordinators, supervisors. Site training involves the ICH GCP training, Ethics Training, Protocol training, training on filling Case Report Forms, Site Master File and logs and forms.
Interim Monitoring Visits will be done during the course of the conduct of the trial by the Clinical Research Associate. Site will be monitored according to the ICH-GCP guidelines as well as the Indian GCP guidelines and SOPs.
Site Closeout Visit will be scheduled after the Study Report is prepared. The monitor will write and submit the Site Closeout Visit Report to the Sponsor/CRO within the due period after close-out.
When all issues are resolved, the monitor will send a closeout letter to the Principal Investigator, with a copy to the Study Coordinator, summarizing all issues and actions items have been resolved.
Monitoring activity is driven by monitoring plans which include the number and frequency of visits to trial sites to ensure the compliances to the study protocols. In general schedule of site visits is planned as below which can be then modified as per protocol requirement;
- The first monitoring visit will take place soon after the enrolment of the first five subjects.
- Interim monitoring visits will be conducted at each site as per the subject recruitment approximately at 10% and 100% enrollment, completion of second visit and after the last patient’s last visit.
- Site Initiation and Close out visits will be conducted at site at the start and after preparation of study report respectively.
Revision of this plan may be based on enrollment rate, detection of any significant protocol violation, lack of investigator compliance with the protocol, a change in investigator’s staff, report of a serious adverse event and/or in case an audit is planned at the site.
At each monitoring visit the Clinical Research Associate (CRA) will review the Investigator Site Master File, pharmacy records (storage conditions, IP expiry dates, accountability, return and destruction of IPs, shipment records), informed consent forms, subject histories, screening record, source documentation, laboratory data, correspondence records, shipment records etc.
Monitor Activities during Site Visits:
During routine site visits, the CRA will verify that the conduct of the trial is in compliance with the currently approved Protocol; that it is being conducted in accordance with ICH/GCP guidelines and all local regulatory requirements and adheres to site’s current SOPs.
Source Documents are Case Histories, Physician Notes, Telephone contact documentation, Hospital records. CRFs and logs will be verified against source documents to confirm accurate, complete and legible reporting of valid data. For this protocol, the verification process will include:
- 100% verification against source of all data for all subjects at each site.
- 100% verification of all key data as indicated below for all subjects:
- The consent form used is the current EC approved form and has a valid EC approval date on the form and that the consents have all required signatures and dates;
- Inclusion/exclusion criteria;
- Investigational product administration
- Safety concerns including documentation of all adverse events and serious adverse events (SAEs) have been reported to CRO/Sponsor.
- Contact list of important CRO personnel with name number and address
- All protocol required clinical tests, activities and observations are completed within the protocol specified timeframe
Contact with sites and correspondence
Site will be instructed to contact the CRO’s study personnel in case of concerns regarding the Protocol, CRF and logs. Site visit reports will talk about the discrepancies in data and clarification will be sought from the site.
REGULATORY FILING AND APPROVAL:
We have ample experience in filing and approval in the DCGI office. We submit applications as per pre-screening checklist and ensure the complete documentation as per the CDSCO requirements mentioned on their website. Our regular follow ups help us to track the application properly and ultimately timely approval. We have experience of dealing with all kinds of applications like new drugs, biological-vaccine & r-DNA, cosmetics, medical device, fixed-dose combination (FDCs), global clinical trials and BA/BE for export etc. The application for the permission of carrying out a clinical trial is made to the office of DCGI. We assist in review and application of the dossier to different committees and also assist in presentation to SEC committees.
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