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
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.
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
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
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
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.
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.
Friday, December 24, 2010
Conduct of Clinical Research study
Conduct of Clinical Research study