NCST DocumentNCST — Clinical trial insurance policy, revised December 2012
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National Policy Requirement and Guidance for the Provision of Insurance Cover for Research Participants in Clinical Trials in Malawi — Revised Second Edition is published by National Commission for Science and Technology. This document is identified by its title; no separate official document code is recorded.
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National Policy Requirement and Guidance for the Provision of Insurance Cover for Research Participants in Clinical Trials in Malawi — Revised Second Edition
Complete twelve-page December 2012 revised second-edition policy, including all nine main sections, study categories, eleven review criteria, seven insurance-certificate bullet fields, both footnotes, source contacts, acknowledgment and contents. Section 2.3.1.5 explicitly includes a trial involving a medical device that has not been prequalified by WHO and approved for usage; other studies are subject to case-specific committee determination. The source requires no-fault insurance while retaining causal connection between trial participation and harm, local insurer/broker arrangements, site- and trial-specific cover, notarial certification and Reserve Bank approval of fronting arrangements. Coverage during the trial plus five years after completion or closure is an insurance condition, not a device-variation approval period. Professional indemnity/malpractice insurance is expressly excluded as a substitute. Original misspellings, 2.4.2 numbering, 2.2.1/2.2.2 cross-references and historical COMREC/drug-authority names are preserved. The source month and edition are document context; no exact publication or commencement date is inferred from the 2025 upload path. The 2008 predecessor, subsequent changes, committee authority and current implementation remain under review; excluded from default current-law discovery.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.