Process and methods
Clinical trial reports and protocols must be made available for relevant clinical studies; the remainder must be available on request. The information that NICE requests in appendices is needed by the ERG to fully critique the submission. The appendices are not normally provided to the appraisal committee or published on the NICE website; please send these as separate documents to the main submission.
Appendices should start at C, because document A is the submission summary and document B is the main submission.
Appendix C: European public assessment report, summary of product characteristics/information for use, scientific discussion or drafts
Appendix D: Identification, selection and synthesis of clinical evidence (see section 3.1)
Appendix E: Subgroup analysis (see section 3.7)
Appendix F: Adverse reactions (see section 3.10)
Appendix G: Cost and healthcare resource identification, measurement and valuation (see section 4.2)
Appendix H: Checklist of confidential information
Any additional appendices should start at appendix I.