If applying for Expedited review mention the category (ies) under which the proposal may qualify for consideration (as per the below criteria) in the application submission page.
Proposals that pose no more than minimal risk may undergo expedited review, for example:
- research involving non-identifiable specimen and human tissue from sources like blood banks, tissue banks and left-over clinical samples;
- research involving clinical documentation materials that are non-identifiable (data, documents, records);
- modification or amendment to an approved protocol including administrative changes or correction of typographical errors and change in researcher(s);
- revised proposals previously approved through expedited review, full review or continuing review of approved proposals;
- minor deviations from originally approved research causing no risk or minimal risk;
- progress/annual reports where there is no additional risk, for example activity limited to data analysis. Expedited review of SAEs/unexpected AEs will be conducted by SAE subcommittee; and
- for multicentre research where a designated main EC among the participating sites has reviewed and approved the study, a local EC may conduct only an expedited review for site specific requirements in addition to the full committee common review.
- research during emergencies and disasters (See Section 12 of ICMR Guidelines 2017 for further details).
List of documents to be included in the application:
- Covering Letter (include list of all documents submitted along with version and date, as applicable)
- Completed CCDC-IEC Proforma
- Full study protocol
- Study Summary, not more than 1-2 page(s) (include study flow chart)
- Study Questionnaires/Interview guides in English and applicable languages
- PIS & ICF’s in English and applicable languages
- CV’s of all Investigators (PI & Co-I’s)
- Ethical clearances from other EC’s, if applicable
- Regulatory clearance letters from HMSC, if applicable
- Any other relevant document/information