Conduct of Clinical Research Study

Role	Responsibility
Study Coordinator	· Maintain and update the study plan for managing clinical data collected in accordance with protocol specifications and/or requirements. · Receive data and log receipt of CRFs in a timely and appropriate manner. · Transfer or hand-over received CRFs to the relevant entry personnel for processing. · Perform overall discrepancy resolution and data validation checks in line according to agreed timelines. · Resolve all coding issues prior to locking the database. · Reconcile the SAE data with adverse event data collected in the clinical study in line with the SOP on SAE Reconciliation. · Create, submit and manage queries to investigator or clinicians monitor the clinical research trial. · Manage data updates and/or query closure(s) responses from the investigator or monitoring personnel. · Manage the timely loading of electronic data from external sources (e.g., patient positions, site and investigator information from C3PR; laboratory data; or, other electronically submitted data for the conduct of the clinical trial). · Manage clinical study conduct activities through data freeze and lock activities. · Manage the export of extract data views or datasets to clinical trials personnel (e.g., statistician for analysis; PI or clinical monitoring personnel for data review; QC for audit activities, etc.). · Ensure coding of data are consistent with the coding guidelines as detailed in the plan for the specific study. · Log all coding discrepancies or non-matches. · Take action on coding discrepancies with the Drug Safety Office in a timely and consistent manner for resolution. · Manage timelines for issue resolution and communicate coding review completion to clinical data manager.
Data Entry	· Input CRF response data received in line with this SOP. · Manage the timelines for completion of the data entry activities to meet study milestones. · Flag or indicate any outstanding data entry issues or items for review and resolution by data management or clinical monitoring personnel. · Update data, when applicable, and when access is appropriately assigned.
Clinical Investigator	· Review data queries to respond to concerns or questions from clinical data management. · Resolve queries by appropriate means (e.g., data correction; no additional information; data recorded is correct). · Contact the clinical data manager if additional clarification is required. · Resolve with Clinical Data Manager any clarification issues.
Drug Safety Office	· Provide input required during coding review in a timely and adequate manner and according to request submitted. · Provide all drug safety input required for resolution of coding review issues. · Assist in reconciling the adverse events capture in the Safety Database with the adverse events captured in the clinical data database - in line with SOP on SAE Reconciliation. · Assure drug safety requirements are met according to protocol requirements and regulations, prior to unblinding
Local QA	· Assure all data are entered and cleaned in line with the GCP guidelines. · Audit data to verify all quality standards are met during performance of the process. · Suggest necessary corrections and assure changes are implemented, making the rationale behind changes clear and fully understood. · Provide detailed advice / guidance on any data quality matters. · Assure that error levels meet the predetermined acceptable levels as defined in the study plan. · Indicate areas of further quality improvement, document recommendations and provide input on issues to the clinical research team members
Statistician	· Assure that there is sufficiently clean data on subjects to run analysis programs. · Work with clinical data manager to update study plan if the statistical analysis plan changes and if those changes reflect collection request for data or new CDEs.
Analytical Programmer	· Review and test analysis programs for functionality, utilizing identified test data and assure that the testing process is closely monitored throughout. · Resolve any analysis program malfunctions to ensure optimal program performance. · Modify analysis programs in line with input from Statistician and following the relevant specifications.

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