important where storage conditions vary from normal practice, e.g. use of refrigerator/freezer. Investigational Product(s) To document that the study X X Where applicable materials have been used accountability at site * according to the protocol. To documents the final accounting of material received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor Documentation of Investigational To document destruction of X X Where applicable unused material by sponsor or Product destruction* (if destroyed at site at site) Decoding procedures for blinded To document how, in case of X X Where applicable an emergency, identity of studies (third party if blinded investigational product applicable) can be revealed without breaking the blind for the remaining subjects' treatment Master Randomisation List To document method for X Where applicable randomisation of study (third party if population applicable) Note this may be a programme rather than a list, and may be held by the Study Statistician. In this case, a Note to File should be added to the TMF, document the name and contact details of the Study Statistician, and the parameters of the randomisation.
important where storage conditions vary from normal practice, e.g. use of refrigerator/freezer. Investigational Product(s) accountability at site * To document that the study materials have been used according to the protocol. To documents the final accounting of material received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor X X Where applicable Documentation of Investigational Product destruction* To document destruction of unused material by sponsor or at site X (if destroyed at site) X Where applicable Decoding procedures for blinded studies To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects' treatment X X (third party if applicable) Where applicable Master Randomisation List To document method for randomisation of study population Note this may be a programme rather than a list, and may be held by the Study Statistician. In this case, a Note to File should be added to the TMF, document the name and contact details of the Study Statistician, and the parameters of the randomisation. X (third party if applicable) Where applicable
Essential-Document-Checklist-non-CTIMPs-v--1.docx