Ann: Trading Halt, page-13

For Phase 2-3 trials:
All the above described expectations for adequate safety elements also apply to Phase 2-3 trials;

Detailed protocols describing both efficacy and safety should be submitted for Phase 2-3 trials. Objectives and purposes of a trial should be clearly stated, including description of the observations and measurements to be made to fulfill the objectives of the trial;

Clinical trial protocols should include a clear description of trial design and patient selection criteria as well as description of clinical procedures, laboratory tests, and all measures to be taken to monitor the effects of the drug;

Previous experience with the proposed primary endpoints should be discussed with relevant scientific references (including any available data regarding the measurement’s validation as relevant to clinical outcomes, biomarkers, or patient reported outcomes);

All potential deviations from trial design should be built in the protocol from the outset, including when adaptive design is considered;

Rules for adverse events’ collection, recording, and reporting should be thoroughly described;

Protocols lacking the necessary elements describing the intended investigations may be placed on Clinical Hold.