Conduct of Clinical Research study

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.