In an RCT, the CONSORT statement requires reporting of which of the following to assess internal validity?

• A The financial budget and institutional approval numbers
• B The lead investigator's qualifications
• C The mechanism of randomisation and allocation concealment method ✓
• D The geographical location of the study centres only

Explanation

CONSORT (Consolidated Standards of Reporting Trials) requires detailed reporting of the randomisation sequence generation method (e.g., computer-generated random numbers) and allocation concealment (e.g., sealed opaque envelopes, central randomisation) as these directly determine susceptibility to selection bias. Inadequate allocation concealment is associated with exaggerated treatment effects. Budget and credentials are not CONSORT items.

Reference: Park's Textbook of Preventive and Social Medicine, 27th ed.

High-yield for: NEET PGINI-CETNExTFMGEUSMLEPLABMRCP

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