CRA
1. Site Feasibility & Qualification
Conduct site feasibility assessments to evaluate: Infrastructure and facility capabilities.Participant pool availability matching eligibility criteria.Investigator and site staff qualifications.Investigator's prior experience in clinical trials. Review PI FQ** and supporting documents.Submit findings to the Sponsor for site qualification and final selection.
2. Legal and Regulatory Agreements signing of essential agreements:Tripartite Agreement between Sponsor, CRO, and Investigator Site.CDA for protecting proprietary information.CTA outlining trial responsibilities, timelines, and compensation.
3. Pre-Trial Preparations**
* Ensure *PMP* and *Delegation of Duties Log (DoA)* are prepared, listing responsibilities of each staff member.
* Organize IMs* to:Train trial site staff on:* Sponsor SOPs,Protocol requirements, GCP principles,Handling and accountability IMPs,Reporting of AEs and SAEs.
4. Monitoring & Issue Resolution**
* CRA monitors sites for:Discrepancies* in data and documentation.Critical violations or non-compliances.Protocol deviations or deficiencies.Reports findings to the PM. Reviewed by Trial Head and communicated to the *Sponsor*for action and decision-making.
5.Conduct SIV after all essential documents are in place.
* Confirm:Participant Informed Consent* procedures are followed.
IMP storage, handling, and accountability are in compliance.
*Randomization procedures*per protocol design.
Lab certification(e.g., NABL for India) for specimen collection, storage, and shipment.
6. Ongoing Monitoring and Data Verification*
* Conduct SDV of:* ICFs
CRFs,
TMF* and ISF*.
* Follow ALCOA+++ principles:Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, and Available.
* Monitor:variability a
*Use of Concomitant Medications.
AE, SAE, and SUSAR reporting to Sponsor, IRB/IEC, and regulatory authorities within stipulated timelines.
7. Essential Documents and Quality Control* Maintain all Essential Documents in: * ISF,
* TMF,
* CSF.
* Ensure *prospective, progressive, and timely documentation.
* Manage nd outliers in data.
8. Trial Endpoints and Data Management*
* Support data management teams and biostatisticians with:
* Data cleaning and validation.
Achievement of *primary and secondary endpoints.Use of SAP for analysis.Assist in the preparation of the CSR in collaboration with the PI or institution.
9. Safety Oversight and Interim Monitoring Collaborate with Independent Data Monitoring Committee (IDMC/DSMB) for:Reviewing interim analysis results.
Making decisions on trial continuation, modification, or termination based on risk-benefit analysis.
10. Final Reconciliation Conduct SCV to:Ensure completeness of all documents. Verify reconciliation of IMP(used, unused, returned, or destroyed as per SOP). Ensure proper archiving of study records. Confirm final communication with Sponsor regarding remaining obligations.