The clinical trials forms page is designed to assist Investigators and Research Professionals to navigate the forms most frequently required to complete a clinical research trial. Temple participates in a diverse scope of clinical research projects and each project has a unique set of requirements for processing. The Principal Investigator is responsible for properly preparing, submitting, and updated all offices during the conduct of a trial.
Institutional Review Board Forms - this link contains require IRB forms and some optional template forms developed by Office of Clincial Trials and collaborators at OCT.
Additional Oversight Committee Application Forms - this link contains application forms and Instructions for additional oversight committes including Medical Radiation Committee, Institutional Biosafety Committee, Research Review Committee at Fox Chase and more.
Contracts, Budgets and Financial Management Forms - click on this link to access additional information on contracts, budgets and subject reimbursement information required for privately funded clinical trials.
Grant Participant Registration (GPR) Form Now Available- Click here for the GPR Form and Instructions. Use the new form for the correct registration of research subjects to ensure all services are billed according to the terms of the Grant. Study Coordinators must complete a GPR Form each time a Research Subject has a research procedure or test.
Site Regulatory File Table of Content and Trial Operations Checklist- This document has 4 worksheets (Trial Contact information, Regulatory Manual Checklist, Site Performance/Operations Checklist, Study Contact Information) These forms will help investigators organize and retain regulatory and study master files.
Excel worksheet - Must review all "Sheets" in the document as listed at the bottom of the excel document
Patient Monthly Tracking Form - Allows you to summarize your patient activity reports in a monthly format to ensure recruitment goals are shared with all study team members. This is an Excel Spreadsheet. Simply open and print.
Delegation of Authority Log - Principal Investigators may delegate trial related activities to qualified individuals to assist with the conduct of the trial. It is the investigators responsiblity to ensure that these assignments are clearly documented to prevent uncertaintly within the study team roles and to ensure proper personnel are performing study related activity consistent with their level of education/training. This form is started at the start of a trial and maintained within the regulator binder.
Cross Study Tracking Form - Allows you to capture key information about all your projects in one form. This could be used by Investigators, Coordinators or Department Administrators. This is an Excel Spreadsheet. Simply open and print.
Grant Participant Registration (GPR) Form Now Available- Use the new form for the correct registration of research subjects to ensure all services are billed according to the terms of the Grant. Study Coordinators must complete a GPR Form each time a Research Subject has a research procedure or test. Click here for the GPR Form and Instructions.
