Forms, Tools & Templates

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Title Description Category Link
Budget Example Example of a completed Study Budget Budget, Finance & Accounts
Budget Preparation Tip Sheet Best practice tips for preparing a clinical research budget Budget, Finance & Accounts
Budget Template Study Budget template Budget, Finance & Accounts
C-2 Human Subject Voucher Supporting documentation for human subject compensation and out-of-pocket reimbursement Budget, Finance & Accounts
Enrolling Subject and Attaching Research Guarantor Instructions for enrolling a subject and attaching a research guarantor in EPIC Budget, Finance & Accounts
PennChart - Patient Registration Form If you need your patient/subject setup in PennChart within 24 hours Budget, Finance & Accounts
Prospective Reimbursement Analysis Template – Drug Study Complete a Prospective Reimbursement Analysis (PRA) workbook for all protocols utilizing UPHS services or procedures Budget, Finance & Accounts
Prospective Reimbursement Analysis Template – Interventional (Non Drug or Non Device) Complete a Prospective Reimbursement Analysis (PRA) workbook for all protocols utilizing UPHS services or procedures Budget, Finance & Accounts
Prospective Reimbursement Analysis Template –Device Study Complete a Prospective Reimbursement Analysis (PRA) workbook for all protocols utilizing UPHS services or procedures Budget, Finance & Accounts
Prospective Reimbursement Analysis Template – Non-Interventional Study Complete a Prospective Reimbursement Analysis (PRA) workbook for all protocols possibly utilizing UPHS services or procedures Budget, Finance & Accounts
Prospective Reimbursement Analysis Template – Study Activity Grid including Sample Study Activity Grid Complete a Prospective Reimbursement Analysis (PRA) study activity grid for all protocols possibly utilizing UPHS services or procedures Budget, Finance & Accounts
Research Encounter Instructions for creating a research (non-chargeable) encounter in EPIC Budget, Finance & Accounts
Research Related Work Queue Instructions for placing “back office” orders from a provider’s schedule Budget, Finance & Accounts
Scheduling a Research Visit Instructions for scheduling a research visit through the central Registration/Schedgistration Budget, Finance & Accounts
W-9 IRS Form Federal form used to report income paid to an individual Budget, Finance & Accounts
Work Queue Management User Guide User Guide for work queue management for research related professional charges Budget, Finance & Accounts
Chart of Allowable Expenses Guidance for budgeting- chart highlights restrictions placed on federally funded studies Budget, Finance & Accounts
Investigational Product Accountability Study Log Study-level investigational product accountability log (all subjects on one log) Drug/Device
Investigational Product Accountability Subject Log Subject specific investigational product accountability log Drug/Device
Device Investigational Plan Template Guide to developing an Investigational Plan for medical device research Regulatory File
Emergency IND (EIND) Guide Guide to requesting and managing a single patient emergency Investigational New Drug application. Drug/Device, IND/IDE Sponsor
Investigational Device Exemption (IDE) Application Instructions Instructions for completing the application for an Investigational Device Exemption (IDE) Drug/Device, IND/IDE Sponsor
Investigational Device Exemption (IDE) Application Template Template for an application to the FDA for an Investigational Device Exemption Drug/Device, IND/IDE Sponsor
Investigational Device Exemption (IDE) Cover Letter Template Template cover letter to accompany the Investigational Device Exemption (IDE) application Drug/Device, IND/IDE Sponsor
Investigational Device Exemption (IDE) Exemption Request Form Form to request an exemption from IDE requirements for a specific protocol Drug/Device, IND/IDE Sponsor
Investigational New Drug (IND) Application Checklist Checklist to assist in preparing the Investigational New Drug (IND) application Drug/Device, IND/IDE Sponsor
Investigational New Drug (IND) Application Instructions Instructions for completing the application for an Investigational New Drug (IND) Drug/Device, IND/IDE Sponsor
Investigational New Drug (IND) Application Template Template for an application to the FDA for an Investigational New Drug (IND) Drug/Device, IND/IDE Sponsor
Investigational New Drug (IND) Cover Letter Template Template cover letter to accompany the Investigational New Drug (IND) application Drug/Device, IND/IDE Sponsor
Investigational New Drug (IND) Exemption Request Form Form to request an exemption from IND requirements for a specific protocol Drug/Device, IND/IDE Sponsor
Memo from Penn IRB Memo from Penn IRB regarding the IRB not disclosing names of its members. This is a necessary component of the IDE application. Drug/Device, IND/IDE Sponsor
IND-IDE Submision Planner Checklist to assist in preparing the final IND/IDE application package to be submitted to FDA. Drug/Device, IND/IDE Sponsor
Non-Clinical Management Guide Guide to investigator and sponsor teams managing non-clinical studies to capture study-specific non-clinical data, vendor, and other supportive information in support of IND/IDE-ready and marketing applications. IND/IDE Sponsor
GLP Vendor Qualification Form Template to qualify non-clinical vendors IND/IDE Sponsor
GMP Qualification Guide Guide to ensuring vendors providing investigational product are qualified and follow Good Manufacturing Practices IND/IDE Sponsor
IND-IDE Sponsor PSOM Qualification Qualifications for being an IND/IDE sponsor at Perelman School of Medicine at the University of Pennsylvania IND/IDE Sponsor
IND-IDE Sponsor Responsibilities Guide Responsibilities of an IND/IDE Sponsor IND/IDE Sponsor
Investigator Brochure Template Guide for developing an Investigator's Brochure IND/IDE Sponsor
Regulatory History  Log Template for tracking all regulatory submissions of an IND/IDE IND/IDE Sponsor
Site Initiation Visit Checklist Checklist for conducting a Site Initiation Visit IND/IDE Sponsor
Sponsor Monitoring Plan Guide Guide for developing an IND/IDE sponsor's monitoring plan IND/IDE Sponsor
Transfer of Obligations Guide Guide to transferring IND/IDE sponsor obligations to another party CTCU
Trial Master File Template for a Trial Master File IND/IDE Sponsor
Vendor Qualification Guide Guide to qualifying a vendor IND/IDE Sponsor
Correspondence Log Log for documenting correspondence including the date, time, participants, and summary of discussion IND/IDE Sponsor, Regulatory File
Close Out Visit Checklist- Investigator Checklist for closing out a protocol Monitoring
Close Out Visit Checklist- Sponsor Investigator Checklist for closing out a protocol by a Sponsor or Sponsor Investigator Monitoring
Monitoring Visit Report Template for Monitoring Visit review and report Monitoring
On-Site Query Report Form Worksheet for documenting the identification and resolution of queries Monitoring
Site Visit Log Document the dates of Monitoring Visits Monitoring
Recruitment Letter - Physician to Established Patient Template for recruitment letter from an external, referring physician to his/her patient about a research study Recruitment and Retention
Recruitment Letter - Physician to Physician Letter Template Template for recruitment letter from one physician to another about a research study Recruitment and Retention
Recruitment Letter – PI to Patient Template Template for recruitment letter from the Principal Investigator to his/her patient about a research study Recruitment and Retention
Recruitment Letter- Physician to Unknown Potential Subject Template for recruitment letter from a physician to a potential research subject about a research study Recruitment and Retention
Pre-Screen Phone Script (Incoming Call) Pre-screen phone script template for incoming calls from potential research participants Recruitment and Retention; Subject Research File
Pre-Screen Phone Script (Outgoing Call) Pre-screen phone script template for outgoing calls to potential research participants Recruitment and Retention; Subject Research File
Screening and Enrollment Log Document subjects who have been screened and/or enrolled Recruitment and Retention; Subject Research File
Study Admin File_Social Behavioral Template for developing a study administration file or regulatory binder for a social behavioral study Regulatory File
Case Report Form Amendments Log Track Case Report Form (CRF) versions and changes Regulatory File
Delegation of Responsibility and Signature Log Document study personnel and their role on the study, as delegated by the Principal Investigator. Also serves as a signature log to identify signatures on research forms. Regulatory File
ICH GCP Essential Documents Table of regulatory files that should be maintained by the PI and Sponsor throughout a clinical research study Regulatory File
Investigator’s Brochure Addendum Log Track versions of the Investigator’s Brochure Regulatory File
Protocol Amendments Log Track versions of the IRB approved Protocol Regulatory File
Protocol Training Log Log for documenting the training of research personnel on the research protocol Regulatory File
Specimen Preparation Checklist Instructions for collecting, labeling and processing specimens for shipment Regulatory File
Specimen Shipping Log Log the collection and shipment of specimens Regulatory File
Adverse Event Log- Protocol Study-level Adverse Event log (all subjects on one log) Regulatory File
Study Admin File_Device Template for developing a study administration file or regulatory binder for a device trial Regulatory File
Study Admin File_Drug Template for developing a study administration file or regulatory binder for a drug trial Regulatory File
Site Qualification Report Tool for documenting the review and qualification assessment of a site and principal investigator Regulatory File, Monitoring
Adverse Event Log- Participant Subject Adverse Event Log Regulatory File, Subject Research File
Informed Consent Form (ICF) Version Log Tracking log of approvals for Informed Consent Form versions Regulatory File, Subject Research File
Reportable Event Form (Electronic) Form for capturing the details of a Reportable Event for informing a sponsor, manufacturer, or other reporting entity Regulatory File, Subject Research File
Reportable Event Form (Paper) Form for capturing the details of a Reportable Event for informing a sponsor, manufacturer, or other reporting entity Regulatory File, Subject Research File
Participant Visit Schedule Tool for tracking the proposed and actual dates for subject study visits Study Start-Up
Study Feasibility Assessment Tool for assessing the resources, recruitment potential, and logistical considerations of a particular study Study Start-Up
Subject Contact Information Sheet Collect contact information for research subjects Subject Research File
Subject Eligibility Checklist Template for documenting review of Inclusion and Exclusion criteria Subject Research File
Propsective Study Design with no Investigational Product (IP) Template This protocol template is designed to facilitate the process of developing a clinical research protocol that does not involve an investigational product. E.g. Comparative effectiveness study, a cohort design, case control study, etc. Protocol Templates
Clinical Trial Protocol Template This protocol template is designed to help research teams develop a clinical trial protocol that includes an investigational intervention (drug, biologic, vaccine or device). Protocol Templates
Retrospective Study Protocol Template This protocol template is designed to facilitate the creation of a retrospective clinical research protocol. Protocol Templates
Social Behavioral Protocol Template This protocol template is designed to assist in the process of creating a social and behavioral sciences human research protocol. Protocol Templates
Closing an IND Guide to Sponsor How to withdraw an IND application with the FDA. FDA definitions of the various IND statuses are included below for reference purposes. Drug/Device, IND/IDE Sponsor
Closing IDE Guide to Sponsor How to discontinue an IDE with the FDA. Definitions of the various IDE statuses are included below for reference purposes. Drug/Device, IND/IDE Sponsor
IND Annual Report Template Template for completing an IND Annual Report Drug/Device, IND/IDE Sponsor
Principal Investigator Compliance Assessment (PICA) The Principal Investigator Compliance Assessment (PICA) is a tool which can be used to monitor or assess the overall conduct of a study. This document is required for all active, high risk studies conducted at Penn. Monitoring
Monitoring Assessment Guidance Document This document is designed to assist study teams with completing an appropriate monitoring summary for the Penn IRB at the time of continuing review. Monitoring
21 CFR Part 11 Electronic Health Records (EHRs) and 21 CFR Part 11 Study Start-Up
GLP Qualification Guide Guide to ensuring vendors providing investigational product are qualified and follow Good Laboratory Practices IND/IDE Sponsor
CLIA, CAP, Lab References and Lab Director’s CV CLIA, CAP, Lab References and Lab Director’s CV. Documents obtained annually and posted with permission from Dept. of Pathology and Laboratory Medicine, Penn Medicine-HUP Regulatory File, Study Documents
Sponsor - IDE Investigator List Template for the submission to the FDA-CDHR of the semi-annual list of investigators required by 21CFR 812.150 IND/IDE Sponsor