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CRF/e-CRF Completion
Guidelines (CCG)
PRESENTED BY:
Vinay Kasare, Payal Gade, Manali Patil, Dr.Geetu Mohan
SIRO CLINICAL REASERCH INSTITUTE WWW.SIROINSTITUTE.COM
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
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.
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
Roles
Involved
CDM
Analyst/CCG
designer/CDA
PM (CDM)
PM (Clinical
Operations)
Medical
Monitor
Sponsor
SIRO CLINICAL REASERCH INSTITUTE WWW.SIROINSTITUTE.COM
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
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
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:
1. General instructions for an overview of EDC system,
2. List of icons
3. Form-wise data entry
4. Query management
5. SDV
6. Investigator signoff
SIRO CLINICAL REASERCH INSTITUTE WWW.SIROINSTITUTE.COM
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
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
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
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
SIRO CLINICAL REASERCH INSTITUTE WWW.SIROINSTITUTE.COM
Sample Page of CRF
Completion Guideline
References
 GCDMP- CRF Completion
 Guidelineshttps://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
THANK YOU
SIRO CLINICAL REASERCH INSTITUTE WWW.SIROINSTITUTE.COM

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

  • 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
  • 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: 1. General instructions for an overview of EDC system, 2. List of icons 3. Form-wise data entry 4. Query management 5. SDV 6. 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  Guidelineshttps://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
  • 15. THANK YOU SIRO CLINICAL REASERCH INSTITUTE WWW.SIROINSTITUTE.COM