Legally approved 8-Apr-2017
Content development was a logical, thoughtful approach, acknowledging that not one member company protocol was preferred over another, as all meet the GCP and ICH requirements. The main focus was to streamline the content to allow for consistency across the pharma industry.
The structure of the Level 1 and 2 headers are intended to be used/adopted for use without changes. If a section does not apply, retaining the heading and inserting “NA” or “Not applicable” will allow a consistent protocol structure for multiple sponsors across industry. The impact will be that the Investigators, study staff and IRBs will be able to locate the same information in the same place and meaning the same thing across multiple protocols.
The Level 3 headers and lower level headers can be adjusted as needed .
GCP and ICH guidance was reviewed as the initial step for creating common core content. A comparison of the content in the member companies protocols was completed as part of the development of the common core content. With intended focus on sites (investigators/coordinators), the core includes content to (1) evaluate whether a site has the patients/facilities/time to conduct a protocol, and (2) the specific information needed to conduct the protocol. Other items have been placed in appendices (including governance-related text) where they are accessible but do not impact the flow of the core information. The core content guidance provided with the template also suggests that the reader refer to the primary sources of information (e.g. IB), where possible, rather than bulk repetition in the protocol. This organization in the document has the added advantage of streamlining the protocol overall. This streamlining is expected to allow more efficient use of the protocol.
Legally approved 8-Apr-2017
TransCelerate sponsored formation of the Electronic Protocol Advisory Committee to inform the initial development of a common human readable and electronic protocol template and provide a forum for key stakeholders to inform future direction and provide know-how. This Advisory Committee was designed to be similar to, but lighter version of, the Coalition for Accelerating Standards and Therapies (CFAST) structure. Input has been received from some eProtocol Advisory Committee members, and additional input is being requested. The intent is to promote “energy” around the idea of an eProtocol platform, and to drive alignment around end to end traceability, automation, and reuse. Through this Advisory Committee, TransCelerate workstreams will continue to get advice, and access to external “know-how.” The groups across the bottom of this slide are not directly involved in this Advisory Committee, but their outputs have been considered in developing the CPT, and their influence is considered via the other Advisory Committee channels. Tufts was consulted specifically regarding CPT project scope, priorities, and deliverables. The SPIRIT checklist was a key reference and influenced the creation of the text-based structure and content. A consultative meeting was held with the Budapest Working Group, with additional input pending. It is envisioned that additional advisors, such as HL7 and IHE, will be pursued as we move toward development of the machine-readable template
Legally approved 8-Apr-2017
Content development was a logical, thoughtful approach, acknowledging that not one member company protocol was preferred over another, as all meet the GCP and ICH requirements. The main focus was to streamline the content to allow for consistency across the pharma industry.
The structure of the Level 1 and 2 headers are intended to be used/adopted for use without changes. If a section does not apply, retaining the heading and inserting “NA” or “Not applicable” will allow a consistent protocol structure for multiple sponsors across industry. The impact will be that the Investigators, study staff and IRBs will be able to locate the same information in the same place and meaning the same thing across multiple protocols.
The Level 3 headers and lower level headers can be adjusted as needed .
GCP and ICH guidance was reviewed as the initial step for creating common core content. A comparison of the content in the member companies protocols was completed as part of the development of the common core content. With intended focus on sites (investigators/coordinators), the core includes content to (1) evaluate whether a site has the patients/facilities/time to conduct a protocol, and (2) the specific information needed to conduct the protocol. Other items have been placed in appendices (including governance-related text) where they are accessible but do not impact the flow of the core information. The core content guidance provided with the template also suggests that the reader refer to the primary sources of information (e.g. IB), where possible, rather than bulk repetition in the protocol. This organization in the document has the added advantage of streamlining the protocol overall. This streamlining is expected to allow more efficient use of the protocol.
Legally approved 8-Apr-2017
Backbone contains the protocol information common to all phases, populations, and therapeutic areas. The core is streamlined and focused on the sites’ needs.
Libraries group and store content to be inserted into the core backbone and contain specific information related to therapy, country, study population (e.g., patient, healthy volunteer) needs.
Appendices provide additional information that can be accessed when needed (e.g., abbreviations, company specific content). Appendices are omitted if not applicable.
Highlight that the template is for all TAs. Additional content available for some specific therapeutic areas.