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Collect necessary data only.

CRFs should focus on collecting only applicable data in alignment with regulatory needs.

The protocol should clearly state which data will be collected in the study.

CRF development should be a controlled, documented process that incorporates (as applicable):

• Design
• Review
• Approval
• Versioning
• Printing
• Distributing CRFs
• Accounting for unused CRFs

CRF development should be controlled by standard operating procedures (SOPs) covering these topics, as well as training.

The CRF design process should include adequate review and approval steps, and each reviewer should be informed on the scope of the review they are expected to provide.

The team that designs the data collection instruments for a study should be involved in the development of the protocol and should have appropriate expertise represented on the CRF design team, including the following:

• Scientific experts should provide sufficient information to ensure data standards staff, subject matter experts, and data management staff understand the background, context, and scientific relevance of the efficacy and/or safety data.
• Data management, standards subject matter experts, and CRF designers should review the protocol to ensure that proposed data can be collected and should ensure that appropriate standards are used to develop the CRF.
• Statisticians should review the CRF against their planned analyses to make sure all required data will be collected in an appropriate form for those analyses.
• Operations staff should review the CRF to make sure the questions are unambiguous, requested data can be collected, and for compatibility with common workflow and procedures.
• Programmers should review the CRF to ensure that the manner in which the data are collected on the CRF is consistent with relevant metadata standards.
• Regulatory experts should review the CRF for compliance with all applicable regulations.
• Data entry staff

  Jira
  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-439

  should review the CRF to ensure that the data are collected in a form that can be entered accurately.

Ideally, the CRF should be developed in conjunction with the protocol (and the SAP, if available).

All research-related data on the CRF should be addressed in the protocol to specify how and when it will be collected.

Translations of CRFs into other languages should be done under a controlled process by experts who understand both the study questions and the language and culture for which the CRF is being translated. The translation should be a parallel process following the same set of steps with separate reviews and approvals by the appropriate experts. Translations may require author approval and a separate validation of the translated instrument.

CRFs that are translated into other languages should follow the same development process as the original CRF to ensure the integrity of the data collected.

Consideration of translation should be part of the CRF development process. Avoid the use of slang or other wording that would complicate or compromise translation into other languages.

Cultural and language issues should be addressed appropriately during the process of translating CRFs to ensure the CRF questions have consistent meaning across languages.

Data that are collected on CRFs should be databased.

For some fields, such as “Were there any Adverse Events?" the response of "Yes/No” may need to be databased but will not be included in tabulation datasets.

Some fields, such as Investigator’s Signature, can be verified by the data entry staff, but an actual signature may not be databased unless there is an e-signature.

If certain data are not required in the CRF, but are needed to aid the investigator or monitor, those data should be recorded on a worksheet (e.g., entry criteria worksheet, dose titration worksheet).

All such worksheets should be considered source documents or monitoring tools and should be maintained with the study files.