1. Identify the Need

Any ISARIC staff or research partner may propose the development of a new archetype CRF. The justification, specific requirements, and objectives of the CRF can be proposed to the ISARIC CCP team at data@isaric.org.

2. Initial call with CCP coordinator

The CCP Coordinator will hold an initial call with the CRF Initiator to discuss the proposed CRF, methodology, timelines, available ISARIC tools (e.g. BRIDGE, CRF library), and the experts who may need to be involved. The Coordinator will also advise on the information required for the endorsement process.

3. Endorsement of Action

Where the topic is outside of the scope of ISARIC’s activities, the CCP Coordinator will liaise with the ISARIC ARChetype CRFs Approvers Committee to obtain a decision on endorsement and progression of CRF development. They will consider:
(a) the public health impact of the disease/syndrome;
(b) existing research efforts to address the objectives proposed;
(c) engagement of appropriate stakeholders;
(d) ISARIC’s ability to add unique value to global evidence generation efforts through development of the CRF.

Note: activities of phases 2–3 below may be initiated in parallel to the endorsement process to speed up the process in the event of an active outbreak.

1. Roles, Responsibilities and Expert Identification

CRF Initiator:
Responsible for drafting and developing the CRF, conducting the literature review, identifying and engaging relevant experts, and establishing a Steering Committee from among the expert reviewers.

CCP Coordinator:
Oversees the CRF creation process, ensures that timelines are met, supports methodological decisions, and connects the Initiator with appropriate experts and stakeholders.

Expert Reviewers:
Subject matter experts, partners in affected regions, researchers with relevant publications, clinicians with patient-management experience, data managers, global health actors, and regulatory bodies who provide technical and contextual input to inform the CRF.

Steering Committee:
A subset of expert reviewers who review early drafts of the CRF, provide structured feedback, and advise on variable inclusion, removal, and refinement.

ISARIC ARChetype CRFs Approvals Committee:
Provides final approval of the CRF and offers high-level feedback to ensure alignment with ISARIC standards and broader global research priorities.

2. Review Relevant Literature and Existing CRFs

The CRF Initiator reviews existing literature, clinical trials, guidelines, and published CRFs related to the disease.

The Initiator may also contact expert reviewers to request CRFs they have used previously in similar clinical or research contexts.

This evidence base informs variable selection, and the overall scope and structure of the CRF.

3. WHO Consultation

The CCP Coordinator or their delegate will contact WHO to obtain a copy of any related WHO CRFs, then discuss how the CRF and research questions can support WHO’s related initiatives and what parties should be involved in its development. WHO feedback will be incorporated as much as possible by iteration of the required steps above or below.

1. Framing Research Questions and CRF Content

Working with the Steering Committee, the CRF Initiator will define the key research questions to be addressed by the CRF.
Based on these questions, the Initiator will map the relevant variables needed to capture essential epidemiological, clinical, laboratory, and outcome data.

2. Create First Draft CRF

Using ISARIC BioResearch Integrated Data Tool Generator (BRIDGE), the Initiator will develop an initial version of the CRF that:

• incorporates all mapped data points;
• uses standardised variables available in the ISARIC Analysis and Research Compendium (ARC);
• drafts new variables where no suitable ARC structures exist.

This first draft will form the basis for subsequent expert review and refinement.

1. Steering Committee Review of First Draft

The first draft CRF will be shared with the Steering Committee via a shared document. Comments and edits will be collected during a review period defined by the Initiator, relative to the urgency of the need for the CRF.

2. Consider disease/syndromic relevance to CEPI

If within CEPI's scope of interest, the CCP Coordinator or their delegate will share a copy of the CRF to request review and the addition of any variables that are valuable to CEPI's activities.

3. Wider Expert Community Review of Revised Draft

Following incorporation of Steering Committee (and CEPI, where relevant) feedback, the revised draft CRF will be shared with the wider expert community. Expert reviewers will be invited to provide additional comments to ensure the CRF is comprehensive, feasible and aligned with current practice. All reviewers will be invited to add their names to the reviewer list on the CRF for attribution of input.All reviewers will be invited to add their names to the reviewer list on the CRF for attribution of input.

4. Consolidation of Feedback and Endorsement

The CRF Initiator will summarise all comments received and, in consultation with the CCP Coordinator and key experts, will revise the draft accordingly.

1. Drafting Collaborative Version in BRIDGE

The CRF Initiator will transfer the collaboratively refined draft CRF into BRIDGE.

All variables should be mapped to existing ARC variables, and any clashes with existing ARC structures must be identified and listed for review.

Newly proposed variables must be prepared in the following format: variable name, variable definition, and proposed section for inclusion.

2. Integration of New Variables into ARC

Newly proposed variables will be reviewed by the Data Team against the ARC Variable Inclusion Rules (see below).

This review will determine whether each variable meets criteria for clinical relevance, scientific justification, non-duplication and suitability as a raw variable, and will ensure correct placement, naming conventions and coding within ARC.

Approved variables will be integrated into ARC, and clashes or overlaps will be resolved in consultation with the Steering Committee and the ARChetype CRF Coordinator as needed.

3. CRF Piloting in REDCap

A pilot version of the CRF will be generated using the BRIDGE data dictionary and tested in REDCap (or a similar electronic data capture platform).

Users participating in the pilot will provide feedback on usability, clarity of questions, workflow logic, branching, timing and feasibility of data entry. All feedback will be logged and reviewed.

4. Complete Final Version for Approval

Following piloting, the CRF Initiator will review and summarise pilot feedback and implement necessary modifications to the CRF.

The final version of the CRF will then be submitted to the ISARIC ARChetype CRFs Approvals Committee for review, high-level feedback and final endorsement before implementation.

1. Release Final CRF

The final approved CRF will be added to BRIDGE and made available through ISARIC communication channels for use by the network.

Documentation and accompanying guidance will be uploaded to ensure users have clear instructions on implementation.

2. Create Synthetic Dataset and Perform VERTEX Test

The Data Manager and Data Scientist will generate a synthetic dataset using ARC-aligned variable structures and REDCap or other synthetic data generation tools.

The CRF will then be tested in VERTEX using this synthetic dataset to confirm compatibility, correct variable mapping, structural integrity, and expected performance within VERTEX.

3. Launch Response Page and Prepare for Publishing

A response page will be launched containing the CRF, documentation, and instructions for use.

Materials will be prepared for publishing at the ISARIC Summit or other dissemination events to announce availability of the new ARChetype CRF.