CT SOP version no 1.0.

Main changes from LM SOP 4.02: Adapted to the clinical trial regulation.

The sponsor has overall responsibility for ensuring that this SOP is followed.

The sponsor’s responsibilities shall be described in the quality system of the sponsor institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.

The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a third-party vendor such as a Contract Research Organisation (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf. Transfer of duties shall be specified in a written agreement.

The coordinating investigator has the responsibility for managing IMP at the end of a trial and filing documentation in the trial master file (TMF) according to the requirements of this SOP.

The principal investigator at each site is responsible for managing IMP at the end of a trial at his/her site and filing investigational medicinal product documentation in the investigator site file (ISF).

Final Disposal of IMP

As a general rule, all IMPs which were delivered from the centre should be returned to the centre, whether it is unused IMPs or empty packaging.

Returned IMPs will be counted and documented, and compliance will be calculated unless agreed otherwise.

IMP accounting records should be verified to confirm completeness and accuracy. Any discrepancies should be explained and documented.

Destruction of IMPs must be done according to established pharmacy or hospital/institution procedures and as agreed with the project leader.

For unauthorised IMPs and unauthorised auxiliary medicinal products, a total reconciliation should be performed, see IMP Reconciliation - Template, and destruction should be documented, see IMP Destruction - Template. 

• IMP Reconciliation - Template
• IMP Destruction - Template
• Checklist Completion of Clinical Trial - Sponsor - Template
• Checklist Completion of Clinical Trial - Centre - Template