Mapping Table Exercise

Mapping Table Exercise

Purposes: To facilitate use of the CPT within your organization by ensuring alignment of your company’s protocol content needs to the TransCelerate Common Protocol Template (CPT) by

· mapping the location of content in the CPT as compared with your company template – this will facilitate populating the CPT

· determining if content used in your company template is missing in the CPT - this

o allows for identification of any gaps (information in your company template that does not appear in the CPT)

o triggers the need to identify where (other than the protocol) within your organization this information is found (eg, CTA, Monitoring Guidelines, Standard Operating Procedures, policy documents).

Mapping Instructions:

Map your protocol template to the TransCelerate CPT

· Compare the headings and subheadings of your protocol template with those in the TransCelerate CPT (see example below) – this will allow users to easily find the appropriate sections where content should be included in the CPT

· Compare the content of corresponding sections (your protocol template to those in the TransCelerate CPT). Identify any missing information (gaps) that are important to your company.

· If gaps are identified, work with your internal functional representatives to identify if this information is adequately covered elsewhere within your organization (eg, CTA, Monitoring Guidelines, SOP/Policy documents), where else in your company it can be captured, or if it needs to be included in your protocol template.

· Below is an illustrative example of how a company’s template might map to the TransCelerate template.

TransCelerate Heading / Section/lINK IN toc / Comments/GAPS
TransCelerate / Current Tempate
Study Rationale / 3.1. / 1.3. Overall Rationale For The Study / NI
Objectives and Endpoints / 4. / 2. Objective[s] And Hypothesis[es] / NI
End of Trial Definition / 5.3. / 17.9.1. Study Completion/End Of Study / Timeframe for final data to be sent from the study site to the sponsor after completion of the final subject at that study site is in company template but not in CPT. Identified that this is captured in the Clinical Trial Agreement.
Pregnancy
Collection of Pregnancy Data / 9.2.5.
Appendix 5 / 12.3.3. / NI
Adverse Events
Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow up and Reporting / 9.2. Adverse Events
9.2.1.Time Period and Frequency for Collecting AE and SAE Information
9.2.2. Method of Detecting AEs and SAEs
9.2.3. Follow-up of AEs and SAEs
9.2.4. Regulatory Reporting Requirements for SAEs
Appendix 4 / 12. Adverse Event Reporting
12.1. Definitions
12.1.1. Adverse Event Definitions and Classifications
12.1.2. Attribution Definitions
12.1.3. Severity Criteria [if applicable]
12.2. Special Reporting Situations
12.3. Procedures
12.3.1. All adverse Events
12.3.2. Serious Adverse Events
12.3.2. Serious Adverse Events
12.4.Contacting Sponsor Regarding Safety / Details of SUSAR reporting is in company template but not in CPT. Identified that this is captured in POL-XXX.
Assessment of Causality in CPT; specific Attribution Definitions in company template, not in CPT – Need to assess impact.
-- / --
Section 9.2.4 of CPT includes:
The Sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a product under clinical investigation. The Sponsor will comply with country specific regulatory requirements relating to safety reporting to the regulatory authority, IRB/IEC, and investigators / 13. Product Quality Complaint Handling / Missing -
Is this text from CPT sufficient or do we need to identify where, other than in the protocol, this is covered?

NI = No impact