7. Do staff preparing the product need to be trained in the protocol?

Yes, Part 2, 2 of SI 2004/1031 (as amended) requires that each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks. Staff preparing product therefore need to be trained in the trial-specific requirements of the protocol applicable to the preparation of product, to ensure adherence to the trial protocol and preserve the credibility and integrity of the data.