Prepare the right documents for the right review.

Identify the applicable review route

Assess the protocol, product, phase, risk, funding and study institutions. Confirm whether review belongs with a recognized IRC or the national NHRC ERB and whether DDA authorization is required. International or multicentre arrangements may add documentation and joint-review requirements.

Scope submission coordination

Coordination and submission support only—not approval services.

• Current-checklist review and document-gap tracking
• Protocol and participant-material version control
• Investigator and institution documentation coordination
• NHRC submission and DDA-related documentation where applicable
• Response, correspondence and approval-condition tracking
• Amendment, renewal and final-report coordination

Distinguish approval from imports and registration

An ethics decision is not an investigational-product import licence, and a registry entry is not a trial permit. Establish the required sequence with NHRC and DDA. Avoid assuming that a single submission completes every institutional, product or transport obligation. Include NCTR and the appropriate internationally accepted registry in planning. Resources provides the NHRC portal links and WHO recognition lists.

Keep the approval conditions visible

Create a calendar for expiry dates, continuing reports, safety notices and changes requiring review. Use the requirements attached to the actual study decisions and confirm current authority instructions. Timelines and approval outcomes are determined by the responsible authorities.