CRF / e-CRF Completion Guidline (CCG).pptx

What are CRF completion guidelines?
A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF and protocol. There is no standard template for CRF completion guidelines as it is study specific.
Case Report Forms (CRFs) are a common data collection mechanism in clinical studies and are sometimes the original recording of study data. CRF completion is one of the earliest opportunities to assure accurate and complete data and to decrease downstream work associated with identification and resolution of data discrepancies. This ppt covers development, maintenance, and implementation of instructions for CRF completion, also called CRF Completion Guidelines (CCGs).
An eCRF (electronic case report form) is a software system used to collect data in a clinical study. Commonly, eCRFs are web-based applications containing various data forms and fields designed to receive data in clinical trials or observational studies.
With the help of eCRFs, all data can thus be validated in real time, whereas with paper-based test forms, this can usually only be done by hand afterwards. If errors are discovered in a paper-based study at a later point in time, for example, when evaluating the data, it is often almost impossible to correct them.
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1. CRF/e-CRF Completion Guidelines (CCG) Presented by: Vinay Kasare , Payal Gade , Manali Patil , Dr.Geetu Mohan Siro Clinical Reaserch Institute www.siroinstitute.com

2. Contents What is CRF Completion Guidelines? Purpose Roles involved Uses Minimum standard required for CCG creation Creation and finalization Example of instruction provided in CCG How to handle changes after go-live References Siro Clinical Reaserch Institute www.siroinstitute.com

3. What is CRF Completion Guidelines? Also referred to as CRF/e-CRF manual. CRF/e-CRF Completion Guidelines (CCG/e-CCG) is a document that has detailed Instructions about completing all fields present on Case Report Form. In case of electronic data capture studies, CCG also consists of instructions related to logging in into database, creating subject, actioning queries and performing data entry. Siro Clinical Reaserch Institute www.siroinstitute.com A CRF completion guideline is  a document to assist the investigator to complete the CRF in a step by step manner  and is drafted concurrently in line with the CRF and protocol.

4. Purpose To increase data accuracy and consistency. To provide traceability for decisions made during data collection. To decrease downstream work including data queries, monitoring questions, and audit findings. Siro Clinical Reaserch Institute www.siroinstitute.com

5. Siro Clinical Reaserch Institute www.siroinstitute.com

6. Uses CCGs are developed for the use of study personnel, usually site coordinators and monitors. Field-wise instructions to ease data entry. CCGs provide solutions to challenges that may be faced by site personnel during data entry. For e.g. Start date of a medication is unknown. Best estimated date can be entered OR unknown date and month acceptable(may vary). Siro Clinical Reaserch Institute www.siroinstitute.com

7. Minimum Standards Required For CCG Creation CRF should: Exist for every study Specify procedures for assuring that data are ALCOA, (ALCOA +) and Traceable. Exist within a quality management system focused on “ensuring human subject protection and the reliability of trial results” Covering the process by which CCGs or equivalent documentation are created, versioned, reviewed, approved, updated, and distributed should exist. Developed for the use of study personnel, usually site coordinators and monitors.   Be concise, current, easy to understand, and available to those performing relevant study operations. Training on CCGs should be provided and documented for individuals with responsibility in observation, measurement, abstraction, and form completion processes. Siro Clinical Reaserch Institute www.siroinstitute.com

8. Creation and Finalization CRF and Protocol play an important role while creating CCG. Insertion of Pictures/images/screenshots. Topics should be considered while drafting CCG: General instructions for an overview of EDC system, List of icons Form-wise data entry Query management SDV Investigator signoff Siro Clinical Reaserch Institute www.siroinstitute.com

9. Creation and Finalization (Contd.) General instructions for an overview of EDC system: Access to study database, changing password, Helpdesk. List of icons: To help understand meaning of each icon in the system. Form-wise data entry: Covers all fields present on CRF. Query management: Answer queries and update data. Source data verification: Verifying forms and updating status to ‘Verified’ (For monitors only) Investigator sign off: Sign off/Approve forms Siro Clinical Reaserch Institute www.siroinstitute.com

10. Creation and Finalization (Contd.) Once draft is ready, it is shared with internal team for their comments. Improvised version is then shared with Sponsor for review. Once all comments are addressed, CCG can be finalized and shared with all concerned personnel. Siro Clinical Reaserch Institute www.siroinstitute.com

11. Example Of Instruction Provided In CCG Record ‘Date of Birth’ in DD-MM-YY format using calendar icon. Incomplete data is acceptable. Age will be populated automatically once the form ‘Informed consent/Assent date’ and ‘Date of Birth’ is entered. Response should be provided from ‘Male’ or ‘Female’ for ‘Gender’. Response should be provided from ‘White’, ‘Asian’, ‘Black’ or ‘Other’ for ‘Race’. Response to ‘If other, Please Specify’ should be provided if ‘Other’ is selected for ‘Race’. Siro Clinical Reaserch Institute www.siroinstitute.com

12. How To Handle Changes After Go-live If CCG needs to be revised after the study is live, all necessary changes are made by concerned CDM personnel and the draft is shared with internal team for their review. (List of changes made should be collated in section ‘version history’) Once all comments from internal team are incorporated, draft is now sent to sponsor for their review. CCG can be finalized with new version once everyone's comments are addressed. The new version is then circulated to all site team members and monitors. Siro Clinical Reaserch Institute www.siroinstitute.com

13. Siro Clinical Reaserch Institute www.siroinstitute.com Sample Page of CRF Completion Guideline

14. References  GCDMP- CRF Completion Guidelines https://www.trialgrid.com/blog/crf_completion_guidelines.html https://scdm.org/wp-content/uploads/2019/12/GCDMP-CRF-Completion-Guidelines-2019-Revised-Edition.pdf   Siro Clinical Reaserch Institute www.siroinstitute.com

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