SMG 101 - Study Set-up Sponsor Projects20091005150004Drexel University College of Medicine Guidance Documents Study Set-up Sponsor Projects Table of Contents Page 1 of 4 Guidance # SMG-101 Version # 003 Approval Date: Effective Date: Purpose: The purpose of this guidance document is to describe the process for setting up an external sponsor initiated project, entailing both investigator and sponsor responsibilities. Scope: This process applies to all industry sponsored studies conducted at Drexel University College of Medicine (DUCOM). Policy: Initial Site Visit: Both the PI and study coordinator must be present. Financial Disclosure Forms: The PI, sub-investigators, and key study personnel must all complete and sign Sponsor & DUCOM Financial Disclosure Forms. Responsibilities: Principle Investigator (PI) Participates in the initial site survey. Reviews the protocol to determine the feasibility of conducting the study Makes decision to either accept or decline participation as an Investigator. Conduct Protocol training for study team. Study Coordinator Organizes the initial site survey Reviews protocol and comments to Investigator regarding feasibility. Ensure that trial is listed on www.clinicaltrials.gov. Sponsor Make initial contact with the investigator. Evaluate the site (may or may not conduct an initial site survey as such) Procedure: 1.0 Initial Contact by Sponsor 1.1 Initial contact is made by either phone, email or fax. 1.2 The sponsor provides a site questionnaire that is completed by a member of the department. This information is reviewed by the Investigator prior to submission to the sponsor. 1.3 When or if the questionnaire contains contractual obligations, legal is consulted and if necessary a Confidentiality Agreement is executed.Drexel University College of Medicine Guidance Documents Study Set-up Sponsor Projects Table of Contents Page 2 of 4 2.0 Conduct of an Initial Site Visit 2.1 A possible tour of labs and areas to be used by the sponsor if requested. 2.1.1 Prior to the tour the Study Coordinator notifies the areas to be visited on the tour of the impending visit. 2.2 The Study Coordinator provides the Sponsor with a tour of the University, the clinic facilities, and if being used any Tenet facilities.. 2.3 The Study Coordinator remains with the Sponsor representative for the entire survey. Any conversation during the tour should NOT include other active studies or other DUCOM proprietary information. 3.0 Disclosure of Proprietary Information 3.1 No proprietary information is discussed until a full Confidentiality Disclosure Agreement has been executed in full. 4.0 Receipt of Protocol and other Essential Study Documents 4.1 A Regulatory Binder is initiated for the study once a CDA has been signed. 4.2 The protocol summary and Investigator’s Brochure are reviewed by the Investigator and study team as appropriate. 5.0 Assessing Study Feasibility 5.1 The Investigator considers the following information in determining feasibility of DUCOM participation in the study. If the Investigator is not adequate in these items, the study is declined: Availability of study subjects that potentially meet inclusion/exclusion criteria. Availability of trained personnel, resources, and appropriate facilities as required. This includes laboratory space, clinical space and imaging facilities. 6.0 Study Disposition (Acceptance or Decline by Investigator) 6.1 Study Declined Procedure: 6.1.1 The Clinical Research Group (CRG) and sponsor are notified that the study was declined. This halts further budget and legal negotiations. 6.1.2 The PI may retain one copy of the protocol information and executed CDA in a secure location for purposes of compliance with the CDA. The protocol may be destroyed as appropriate. 6.2 Study Acceptance Procedure 6.2.1 The PI and Study Coordinator assess the study budget and forward to the CRG for negotiation, as soon as possible. 6.2.2 The CRG is notified and negotiations with the sponsor are initiated.Drexel University College of Medicine Guidance Documents Study Set-up Sponsor Projects Table of Contents Page 3 of 4 7.0 Essential Study Documents: FDA Form 1572 (IND studies only) 1572 equivalent for devices Sponsor & DUCOM Financial Disclosure forms Laboratory certifications and reference ranges CVs, CAP, and CLIA certifications For a study used Tenet pharmacist, a copy of their signed & data CV and license All documents required for IRB approval 8.0 Other Arrangements: 8.1 Necessary study equipment is secured. If clinical equipment is brought into DUCOM facility, then equipment must be calibrated and checked. 8.2 Identification of secure areas for storage of Case Report Forms, investigational product, laboratory supplies, etc. 8.3 Assigning roles and responsibilities to study personnel, including initiation of the Delegation of Responsibility Log (see Guidance Document #REG-106 Delegation of Responsibility). 8.4 Study Team training specific to the protocol is conducted by the PI 8.5 The PI ensures that study team members have appropriate training for any special equipment utilized during the conduct of the study. 8.6 General training of the study team training. Reference:  21 CFR, Part 312 Investigational New Drug Application, April 2007  Guidance ADM-105 Preparation and Execution of Clinical Research Agreements  Guidance ADM-109 Training and Education  Guidance SMG-114 Equipment Maintenance  Guidance REG-101 Preparation and Maintenance of the Regulatory Binder  Guidance REG-102 IRB Communications  Guidance REG-103 Completion of FDA Form 1572  Guidance REG-106 Delegation of