Clean File_Form_Lock_Katalyst HLS
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Clean file can be declared when all required data management activities have been completed as per the data management plan. This includes final reconciliation of external vendor data, completion of coding and discrepancy management activities, and signing off of all CRFs by the principal investigator. The data management team's role in clean file includes performing manual reviews, ensuring reconciliation of safety databases, and communicating any issues to monitors during the clean file declaration process.
Clean File_Form_Lock_Katalyst HLS
- 1. Clean File/Form Lock 1 11/20/2017Katalyst Healthcares & Life Sciences
- 2. Icons Used Questions Demonstration Hands on Exercise Coding Standards A Welcome Break Tools 2 ReferenceTest Your Understandin g Contacts
- 3. OBJECTIVES 3 After completing this module you will be able to understand: ➢ What is Clean File? ➢ Procedures required for Clean File ➢ Clean File Checklist and Form ➢ How to declare Clean File ➢ Dos & Don'ts ➢ Importance of Clean file ➢ DM Role in Clean File ➢ Steps to Declare Clean File Objectives
- 4. WHAT IS CLEAN FILE? 4 ➢ Clean File means that the data recorded in clinical trial is clean & ready for Database Lock/freeze ➢ Clean File can be declared for a study when all required data management activities (as per the Data Management Plan) have been completed and documented appropriately ➢ This is the last step prior to database Lock/Freeze usually done once all trial data is received/recorded and data discrepancy is addressed/resolved. ➢ Clean File ensures • Data is complete i.e., No missing data • Data is consistent • Data is accurate • Data is reliable • Data is discrepant free
- 5. PROCEDURES OF CLEAN FILE 5 There are various procedures that are followed for declaring Clean File on the data provided These procedures are as follows: ➢ Manual review : • Listings • Reports • Trackers ➢ Final reconciliation of external vendor (Third Party) data For e.g.. Lab data, Pharmacokinetic data, Pharmaco-genetic data, etc) ➢ Final reconciliation of AE, SAE & Concomitant medications ➢ Completion of Coding activity ➢ Completion of Discrepancy Management activity ➢ Completion of Source data verification ➢ All CRFs have been approved & signed by the Principle Investigator
- 6. ACHIEVING CLEAN FILE: THIRD PARTY VENDOR DATA 6 ➢ Check data query turnaround timelines (with Third Party Vendor) and ensure process for quick turnaround are in place ➢ Validate test transfers thoroughly before getting production data transfers to ensure transfers are as per the specification provided to Third Party Vendors (e.g. of TPV data are safety laboratory data, ECGs, PK, PD, etc.) ➢ Agree and Document: • Variables, Method, format and frequency of data transfer from the provider to Data Monitoring Committee in a Data Transfer Specification • Confirmatory mail is required from the TPV for the final transfer of TPV data • Allow enough time for data validation
- 7. ACHIEVING CLEAN FILE: SAE RECONCILIATION 7 1. Perform Final SAE Reconciliation for the study from FSI date 2. Check for outstanding issues if any i.e. either from clinical database or from safety database and resolve it 3. Check for accepted discrepancies 4. Ensure that final SAE Reconciliation is completed for the study 5. Sign the Final SAE Reconciliation form for archival in Study Master File
- 8. ACHIEVING CLEAN FILE: SAE RECONCILIATION 8 ➢ Examples of acceptable discrepancies that can remain after SAE reconciliation: • SAEs entered in Safety database after data cut off date but missing in the study database • Post-study SAEs are entered in the study database which are not required • An outcome is provided on the Safety database for SAEs resolved outside the follow-up period • Coding Mismatch due to medical equivalence (not exact match) of coding exist in the Safety database and the clinical database. ➢ During SAE reconciliation if an SAE is found missing in the Safety database or if the severity of an existing SAE changes to fatal or life threatening,then DM is responsible for reporting this urgently (latest by the end of the next business day) to the Safety Team Personnel.
- 9. ACHIEVING CLEAN FILE : CODING 1. Coders should ensure that there are no terms with missing dictionary codes in the SAS datasets/study database. 2. Consistency report is generated by the Coder/DM 3.The consistency report is reviewed by the Sr. Coder and then sent to the study physician by the Coder/DM 4.The Study Physician reviews and provides suggestions for recoding or querying 5 The report reviewed by the Study Physician is sent back to the Coder/DM 6. Coder executes the changes as per the suggestions from the Study Physician
- 10. ACHIEVING CLEAN FILE: DATA VALIDATION QUERIES 10 • Central Study Delivery Team and Data Monitoring Committee can decide to use either an email (to be used only if secure) or fax query process at clean file. This process should be decided well in advance before LSLV • Ensure communication strategy is in place so that queries are not overlooked by site staff or monitors • This is critical during final validation otherwise timelines may be jeopardized • Ensure clean patient tracker is filled to track the status
- 11. • The Clean File Checklist facilitates timely submission of an error free Clean File • Clean File Checklist & Form helps in : – Verifying all that is required is in place – Assuring that nothing has been missed out CLEAN FILE CHECKLIST & FORM 11 Clean File
- 12. CLEAN FILE FORM 12 Document the CF decision on ‘Clean File Form’ provided by Client/Sponsor ‘Final or interim’ should be ticked as per the study specifications by Client/Sponsor Tick ALL boxes and add a comment where needed
- 13. CLEAN FILE FORM 13 Clean File declared date : ------------------------ (DD/MM/YYYY) Endorsed by : ----------------------- ----------------------- Study Team leader/Client signature Team Manager / DMTL’s signature Sign and date from SDL and DMTL’s/Team Manger After completion archive Clean File Form in the Study Master File with associated documents to support decisions on the data
- 14. • A Clean File meeting is held with relevant Study Delivery Team members • Relevant team ensures that all activities required to declare Clean File as specified in the Clean File Form/other procedures are reviewed • Clean File decision is taken for all study data • Data Monitoring Committee Representative documents the clean file decision and any critical exceptions on the ’Clean File Form’template • Relevant team ensures that written minutes from this meeting are taken • The Clean File Form is signed and archived in the SMF(Study master file) DECLARING CLEAN FILE 14
- 15. The following factors decide Database lock: • Clean file has been declared for the study • All treatment-revealing data have been transferred • All post transfer consistency checks have been completed successfully • No more additions or other changes to the database are anticipated so the database can be locked & the study can be unblinded. POST DECLARING CLEAN FILE : DATABASE LOCK 15
- 16. • SDT/ LDM/ DMTL ensures that access to the study database is removed or restricted,as applicable • Updates the Database Access List • Ensure that study access is revoked from all the data managers (except LDM and one DM) • Access Restriction can be done prior to Clean File lock POST DECLARING CLEAN FILE: DATABASE ACCESS 16
- 17. Post Clean File data errors and documentation: Database Lock POST CLEAN FILE DATA ERRORS 17 Client/Spons or decision Error Considere d Critical Document Non-Critical Error form Document Critical Error form Query neede d Unlock database Raise query Resolve query Re-extract data Review data errors Update Database Access List Correct Error No Ye s Re-lock Complete the necessary steps as per the Sponsor/Client specifications No Ye s
- 18. Do’s • Discrepancy management activity is performed regularly • Manual review performed regularly • Preparing & sharing Clean File plan during study setup with all study team members • Adhering to the Clean File plan • Inform QA/QC team at least 2 months prior to Clean File date • Proactive communication with the Monitors/Point of Contact for any issues or delays in the study timelines as and when required • Get the Monitoring plan from the Monitors and plan accordingly • Timely documentation of each and every activity • Everyone doing their share of work on time DO’S 18
- 19. Don'ts • Do not keep Pending /Outstanding issues • Do not accept any changes in the database without proper reason for the change • Do not keep a practice of using Note to File/File Note • Do not get scared of escalating issues to the relevant team DON'TS 19
- 20. Helps in timely submission of data for the generation of results, analysis and submissions IMPORTANCE OF CLEAN FILE 20
- 21. • Clean File can be declared for a study when all required data management activities (as per the DMP) have been completed and documented appropriately Data clean activity in a nut shell: • All data have been received and processed • All queries have been resolved • External data (e.g., electronic laboratory data) are complete and reconciled with the study database • If a separate database exists for adverse event database, it is reconciled with the main study database • The coding list has been reviewed for completeness and consistency • Final review of logic and consistency check output has taken place • Final review for obvious anomalies has taken place • A quality audit of the data and the corresponding documentation of the error rate have both occurred • All documentation is updated and stored according to standard operation procedures • In case of the issues observed during clean file declaration (Like missing pages/missing PI Signatures) communicate with the Monitors/Point of Contact & relevant teams DM ROLE IN CLEAN FILE 21
- 22. QUESTIONS 22
- 23. In God we trust! Everyone else must show us the data! 23
- 24. • What is Clean file? • When can you declare Clean file? • DM role in Clean file? TEST YOUR UNDERSTANDING 24
- 25. • Clean File means that the data generated from clinical trial is clean & ready for Database Locking/freezing • Clean File can be declared for a study when all required data management activities (as per the Data Management Plan) have been completed and documented appropriately • These procedures are as follows: ➢ Manual review in the form of Listings, Reports,Trackers ➢ Final reconciliation of external vendor (Third Party) data For e.g.. Lab data,Pharmacokinetic data, Pharmacogenetic data,etc.) ➢ Final reconciliation of AE, SAE & Concomitant medications ➢ Completion of Coding activity ➢ Completion of Discrepancy Management activity ➢ Completion of Source data verification ➢ All CRFs have been approved & signed by the Principle Investigator • In case of the issues observed during clean file declaration (Like missing pages/missing PI Signatures) communicate with the Monitors/Point of Contact & relevant teams SUMMARY 25
- 26. – You have successfully completed - Clean File/Form Lock ThankYou & Questions 11/20/2017 Contact: Katalyst Healthcare’s & Life Sciences South Plainfield,NJ,USA 07080. E-Mail:info@KatalystHLS.com