Nr |
Question |
Answer |
| 1 |
Should the curriculi vitae of the Head of the Laboratory and the pharmacist also be included in the Trial Master File and the Investigator File |
It is recommended to include the CVs of the Head of the Laboratory and the pharmacist if they contribute significantly to the generation of the results. The sponsor has to demonstrate that they have verified the suitability of those persons and their facilities. |
| 2 |
Does the investigator have to sign for the receipt of the investigator's brochure? |
It is not required to document the receipt of the investigator's brochure (sign and date). However, it is preferred to document the receipt of that document. It is possible to document the receipt of this document in the report of the pre-study monitoring visit. For the receipts of updates of the brochure the same hold true. |
| 3 |
What should we do when the patient has forgotten to date the informed consent form? |
The investigator should contact the patient and request him/her to sign the form later. The actual date should be filled out on the form together with a statement why this date is later. This statement should be signed and dated by the patient and the investigator or his/her delegate. |
