Study Titel/ Code: Local Principal Investigator: Site No: = All physical examinations, responsible for clinical decisions = Consenting of patients = Drug/ Device handling, accountability = Other (specify): * 1 5 9 13 2 = Informed Consent signature process 6 = Enrolment patients (Incl/ Excl Criteria) 10 = Laboratory 3 = Routine examinations, scheduling visits 7 = Completion of Source Data 11 = ISF 4 = Screening of patients 8 = Completion of CRF, Forms, etc. 12 = Coordination Name and Title/ Role of Initials Signature Date Key delegated From /To Signature Date (dd/mm/yy) Investigator Teammember Teammember study tasks* From: Name: To: Titel/ Role: From: Name: To: Titel/ Role: From: Name: To: Titel/ Role: From: Name: To: Titel/ Role: Page _____ of _____
Study Titel/ Code: Local Principal Investigator: Site No: * 1 = All physical examinations, responsible for clinical decisions 2 = Informed Consent signature process 3 = Routine examinations, scheduling visits 4 = Screening of patients 5 = Consenting of patients 6 = Enrolment patients (Incl/ Excl Criteria) 7 = Completion of Source Data 8 = Completion of CRF, Forms, etc. 9 = Drug/ Device handling, accountability 10 = Laboratory 11 = ISF 12 = Coordination 13 = Other (specify): Name and Title/ Role of Teammember Initials Signature Teammember Date Key delegated study tasks* From /To (dd/mm/yy) Signature Investigator Date Name: Titel/ Role: From: To: Name: Titel/ Role: From: To: Name: Titel/ Role: From: To: Name: Titel/ Role: From: To: Page _____ of _____