DELEGATION LOG (TASKS DELEGATED FROM Responsible Researcher at Institution) Clinical Interventional Study

Study: (Title and number) Project Manager: Centre No: (Multi centre study) Responsible Researcher at Institution: Task Codes**:

Role*:

A. Obtain Informed Consent H. Report SAE O. Review lab results

Reseponsible Researcher (RR) Other:______B. Assess inclusion-exclusion Criteria I. CRF completion, query resolution P. Allocate treatment/randomisation

Investigator (INV) Other:______C. Record Medical History J. Sign off CRF and queries Q. Unblind, if applicable

Study Nurse (SN) Other:______D. Record Concomitant Medication K. Lab sampling and handling R. Other:______

Lab personnel/bioengineer Other:______Role Name Initials Signature Delegated Protocol- Start RR Stop date RR (pinted) tasks specific date con (dd.mm.åååå) confirmation (from code list) training (dd.mm.yy fir (initials) received yy) ma tio n (init ials )

RR Yes No Role Name Initials Signature Delegated Protocol- Start RR Stop date RR (pinted) tasks specific date con (dd.mm.åååå) confirmation (from code list) training (dd.mm.yy fir (initials) received yy) ma tio n (init ials )

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No DELEGATION LOG (TASKS DELEGATED FROM Responsible Researcher at Institution) Clinical Interventional Study

Study: (Title and number) Project Manager: Centre No: (Multi centre study) Responsible Researcher at Institution: Task Codes**:

Role*:

A. Obtain Informed Consent H. Report SAE O. Review lab results

Reseponsible Researcher (RR) Other:______B. Assess inclusion-exclusion Criteria I. CRF completion, query resolution P. Allocate treatment/randomisation

Investigator (INV) Other:______C. Record Medical History J. Sign off CRF and queries Q. Unblind, if applicable

Study Nurse (SN) Other:______D. Record Concomitant Medication K. Lab sampling and handling R. Other:______

Lab personnel/bioengineer Other:______Role Name Initials Signature Delegated Protocol- Start RR Stop date RR (pinted) tasks specific date con (dd.mm.åååå) confirmation (from code list) training (dd.mm.yy fir (initials) received yy) ma tio n (init ials ) Role Name Initials Signature Delegated Protocol- Start RR Stop date RR (pinted) tasks specific date con (dd.mm.åååå) confirmation (from code list) training (dd.mm.yy fir (initials) received yy) ma tio n (init ials )

Yes No

Yes No

Yes No

Yes No

To be signed by RR at the completion of the study to confirm all information above is correct (Last page) Date Responsible Researcher, printed name Responsible Researcher, signature