STANDARD OPERATING PROCEDURES
For
Start-up of New Clinical Trials
And
Review by Clinical Trials Working Group

• PI Has Preliminary Discussions with Sponsor The sponsor may be a pharmaceutical company, a device company and/or a contract research organization (CRO). The Clinical Trials Working Group does not review federal grant proposals. Please note that the PI is not authorized by the university to agree to budgetary figures proposed by the sponsor at this point.

• Confidentiality Agreement The PI may sign and forward to the sponsor the Brody School of Medicine Pre-Approved Confidentiality Agreement if the sponsor agrees to its use without any changes (a finalized copy must be sent to OSP). Otherwise, the sponsors confidentiality agreement must be submitted to the OSP for review, possible negotiation, and signature.
  

• PI Receives Protocol and Determines Feasibility In addition to the protocol, the sponsor may also send an investigator brochure (for drug studies only) and their proposed budget. It may also be possible to obtain draft Case Report Forms (CRFs) that can prove helpful in determining feasibility. The PI can use the Pre-Study Checklist as a guide in determining whether or not they can and should do the clinical trial. This form is meant for self-examination only and does not have to be submitted to the Clinical Trials Working Group.
  

• Pre-Study Site Visit The sponsor may visit at an early stage of the process in order to see if facilities are adequate (pharmacy/drug storage, clinic space, laboratory, etc.) and to gauge the interest and qualifications of proposed study personnel.
  

• PI Contacts Other Departments to Determine Specific Costs and Prepares Preliminary Internal Budget All tests and procedures required by the protocol for each patient encounter must be considered. Departments such as Pathology, Radiology, Pharmacy, etc. must be contacted if their services will be required in order to determine if they can perform the tests and what the costs will be. UMCIRB fee, study personnel salary, patient reimbursements, advertising, postage/mailing costs, facilities & administrative (indirect) costs, etc. must be included. It may be helpful for the study personnel to refer to the Budget Guidelines document.
  

• Make Submission to Clinical Trials Working Group for Signature Fill out and submit the Clinical Trial Worksheets. Be sure to include salary figures for all physicians, physician's assistants, nurses, and administrative personnel. Also send copies of the 1572 and the protocol. Other documents or additional information the PI feels are pertinent can be submitted at their discretion.
  

• Clinical Trials Working Group Meeting The submitted documents are reviewed. If the material submitted is approved without change, the Clinical Trials Working Group Approval/Action Required Notification letter will be checked appropriately, signed and returned to the PI. If there are concerns and changes are requested, this will be documented in writing on the same form and returned to the PI. The PI can make the changes and re-submit or provide a written statement to the Clinical Trials Working Group providing additional information regarding the concerns.
  

• PI Negotiates Budget with the Sponsor After the PI receives the Clinical Trials Working Group Approval/Action Required Notification letter with the "approved" box checked, they can begin their budget negotiations with the sponsor. Review the Budget Guideline document, which addresses many of the financial aspects of studies including payment schedules and the advantages and disadvantages of each. Please note that the approved internal budget is the cost to do the study. Every effort should be made to maximize financial returns to the university. If the sponsor proposes changes, contact the Clinical Trials Working Group and re-submit.

• Submit Budget Forms and Contract to Administration and Finance/OSP for Signatures These may be found at the sponsored programs website. These include the Multi-Disciplinary Project Form (if multiple departments would be involved), Internal Processing Form, Abstract of Application, Project Classification Form, the finalized Clinical Trial Salary Worksheet, the finalized Clinical Trials Test and Assessment Cost Worksheet (which is found as the 2nd page of the Clinical Trial Salary Worksheet), Contact Sheet, and a draft Contract with Sponsor Budget.  Please note that cost-sharing is not allowed on industry sponsored trials, so do not fill out the Request for Cost-Sharing of F & A Form.
  

• OSP & UMCIRB Submissions While submissions to OSP and UMCIRB can be made simultaneously, the draft contract will be reviewed but will not be signed by OSP until final UMCIRB approval is documented.

• Account Established in Grants and Contracts Administration After approval by UMCIRB and contract sign-off by OSP, an account will be established and the clinical trial can start.
  

• Amendments If at any time, the sponsor proposes changes to the study such as altering the length of the trial, the scope of work (e.g., adding additional patients, visits, studies, etc.), other aspects of the protocol and/or the contract, revised documents should be submitted for approval. This includes submitting revised Clinical Trial Worksheets to the Clinical Trials Working Group and Administration and Finance. If the reimbursement for these changes is approved as indicated by the receipt of a new Clinical Trials Working Group Approval/Action Required Notification letter by the PI, the corresponding amended contract should be submitted to OSP for signature. A UMCIRB Revision Form should be filled out and submitted as well.

• Regulatory Documents Binder The study personnel (PI, study coordinators, administrative employees of the department performing the trial) are responsible for filling out regulatory forms, gathering necessary documents and maintaining them. These can include at study start-up: Photocopy of the FDA 1572 (for drug trials), copy of protocol, Protocol Signature Page, Site Signature Log, Delegation of Responsibility (name and duties of each member of the study team), UMCIRB Committee Roster, Curricula Vitae (CVs) for all members of the study team listed on 1572 including the Laboratory Director (dated within 1 year), medical licenses/certifications of study team members, current CLIA and CAP Certifications for the Pathology laboratory, laboratory test normal ranges, and JCAHO Accreditation letter for hospital if appropriate. Also, keep all approval letters and correspondence.

• Preliminary Compliance Review After receipt of the first patient payment and the corresponding Time and Effort report, the Clinical Trials Working Group will perform an initial compliance review.