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Question What information is entered into the CRIS?
Type Using the system

The information required in the CRIS includes the minimum amount of information defined in WHO Trial Registration Data Set. Besides that information, the CRIS requires some additional information.

The information required for registration in the CRIS is:

(1) Background: public title, and scientific title, etc (2) Institutional Review Board/Ethics Committee: board approval status, approval number and date, name of board, data monitoring committee (3) Contact details of the following persons: contact person for principal investigator/scientific queries, contact person for public queries, contact person for updating information (4) Study status: overall recruitment status, date of first subject enrollment, target sample size, primary completion date, study completion date, and recruitment status by participating study site (5) Source(s) of monetary/material support (6) Sponsor organization(s) (7) Study summary (8) Study design: interventional study(study purpose, phase, interventional model, blinding, allocation, intervention type, intervention description, arm label, target sample size, arm type and arm description), observational study(observational study model, time perspective, target sample size, cohort/group label, cohort/group description, biospecimen collection and archiving, and biospecimen description) (9) Subject eligibility: condition(s)/disease(s), rare disease, and inclusion/exclusion criteria (10) outcome measure(s): type of primary outcome, primary outcome, and secondary outcome (11) Publication information, if applicable.

For more information regarding the required data elements for registration with the CRIS, please refer to the CRIS Registration Data Set,

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