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- 02.04.02 Investigator's Brochure Addendum Log Track versions of the Investigator’s Brochure Trial Documents IB
- 01.01.01 Work Instructions TMF - PennBox Instructions explaining training requirements, user roles, access, and use of the TMF in the Veeva Vault system Trial Master File Trial Master File
- 01.01.01 Work Instructions TMF - Veeva Instructions explaining training requirements, user roles, access, and use of the TMF in the PennBox system. Trial Master File Trial Master File
- 01.02.03 Notice of Disclosure of FCOI Template for written disclosure of FCOI IND; IDE Sponsor
- 01.02.03 Statement of Financial Interest - Sponsor Team Member Form to be used by Penn Faculty or staff of the Sponsor team to state presence/absence of financial interests for a particular study. Sponsor FCOI, Disclosure, Conflict
- 01.03.01 DSMB Charter Used to clearly describe how the DSMB will function, including frequency of meetings, data to be reviewed, how safety items will be communicated, etc. DSMB Data safety monitoring board
- 01.03.02 DSMB Contact List Used to compile contact information for the DSMB members and their administrative support staff. May be useful as a reference during trial progress. DSMB Data safety monitoring board
- 01.03.03 DSMB Meeting Minutes Used to document discussions during DSMB meetings. Includes documentation of attendance and disclosure of financial conflicts. DSMB Data safety monitoring board
- 01.03.03 DSMB Outcome Email Letter Used to document the outcome of the DSMB meeting to provide to the PI(s). The PI may need this confirmation to provide to their IRB or other local regulatory review committee. DSMB Data safety monitoring board
- 01.03.03_DSMB_Report Used to provide a summary of trial data to the DSMB. Specific section will differ by study, may be revised based on DSMB request. DSMB Data safety monitoring board
- 01.03.05 DSMB Qualification Form Used to document potential DSMB member's agreement to serve as part of the DSMB. Includes description of confidentiality and disclosure of financial conflict of interest provisions. DSMB Data safety monitoring board
- 01.05.01 Correspondence Log Template Log for documenting correspondence including the date, time, participants, and summary of discussion Project Management Minutes
- 02.01.01 Investigator Brochure Template Guide for developing an Investigator's Brochure Trial Documents
- 03.01.01 Expanded Access eIND Instructions for submitting an emergency IND request IND Emergency use, Investigational New Drug
- 03.01.01 Expanded Access sIND Instructions for submitting a (compassionate use) single patient IND request IND Investigational New Drug
- 03.01.01 IDE Application Template Original Investigational Device Exemption (IDE) template in accordance with 21CFR812.20 IDE IDE, Device, application
- 03.01.01 IND Application Template Template for an application to the FDA for an Investigational New Drug (IND) IND
- 03.01.01 Submitting to the FDA This document describes the different way a submission can be sent to the FDA. It applies to clinical research (IND/IDE) and also to Expanded Access of drugs and devices. Sponsor Regulatory submissions, CDER, CBER, ESG, CDRH
- 03.01.01 aIDE Application Template Abbreviated Investigational Device Exemption (aIDE) Template IDE abbreviated, IDE, Device, application
- 03.03.02 IDE Progress Report Template Template for completing an IDE Progress Report IDE Investigational Device Exemption (IDE)
- 03.03.02 IND Annual Report Template Template for completing an IND Annual Report IND Investigational New Drug
- 03.03.03 Closing an IND Guide to Sponsor How to discontinue an IND with the FDA. Definitions of the various IND statuses are included below for reference purposes. IND Investigational New Drug (IND)
- 03.04.02 Regulatory History Log Template for tracking all regulatory submissions of an IND/IDE IND; IDE Sponsor
- 05.02.01 IB Signature Page This document tracks the Principal Investigator's acknowledgement of an Investigator Brochure for their IND study. IND Investigator Brochure, Principal Investigator, Investigator New Drug (IND)
- 05.02.02 PI Signature Page The document to be signed by the Principal Investigator of a study at each revision of the study's protocol. Protocol Templates Principal Investigator, Protocol Amendment, Revision
- 05.02.06 Significant Deviation Form This is a form to be used by a Sponsor to document the assessment and impact of deviations associated with clinical trial activities. Sponsor Exception
- 05.02.07 PI Qualification Form Template for documenting the qualifications of a Principal Investigator Sponsor Principal Investigator (PI)
- 05.02.10 Site Financial Disclosure Form Form utilized by the Sponsor to evaluate financial interests of study investigators. Sponsors must evaluate if a financial conflict of interest (FCOI) exists and if management is required based on this information. Refer to Penn Policy on Conflicts of Interest Related to Research for who meets the definition of “Investigator.” Sponsor financial interest, financial conflict of interest
- 05.02.19 IDE Investigator Agreements The investigator agreement of compliance to all requirements of the investigational plan, IDE regulations, and other applicable regulations of the FDA for investigational devices. IDE Statement, Device
- 07.01.01 Work Instructions - Pharmacovigilance Work instructions on sponsor pharmacovigilance (safety) management. This includes a discussion of the sponsor responsibilities related to pharmacovigilance, as well as instructions on conducting the activities, and additional reference resources. Sponsor Sponsor, Safety
- 07.02.02 SAE Form Form used to document an SAE that occurs in a trial and to report the relevant information to the sponsor. Trial Documents Serious Adverse Event (SAE)
- 09.01.01 GLP Qualification Guide Guide to ensuring vendors providing investigational product are qualified and follow Good Laboratory Practices Third Party/ Vendors
- 09.02.03 Transfer of Obligations Guide to transferring IND/IDE sponsor obligations to another party IND; IDE Vendor
- 21 CFR Part 11 for EMR Memo- Penn Medicine Electronic Health Records in Support of Clinical Research Communication; Study Start-Up part 11, 21 cfr part 11, EMR, compliance, pennchart
- CLIA, CAP, Lab References, Lab Director’s CV To obtain documents email: psom-ocrcompliance@pobox.upenn.edu Regulatory File/ Investigator Site File; Source Documentation CLIA, CAP, Lab References, lab director, CV
- CRSPR Email Listserve Clinical Research Staff Portal and Registry (CRSPR) is an email listserve to communicate important, timely information to Penn Medicine's Clinical Research Professionals. Needs PennKey login. Sign up by creating a profile, to receive emails from OCR, IRB, CHPS, etc. OCR Applications CRSPR, listserve, application, email, portal, registry
- Case Report Form Amendments Log Track Case Report Form (CRF) versions and changes Regulatory File/ Investigator Site File CRF
- Clinical Research Resource Feasibility Assessment Budget/ Finance
- 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
- 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
- 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. IDE Investigational Device Exemption (IDE), Closeout
- Cosmos Access Form Complete this form to request access to EPIC/PennChart's COSMOS network for patient data. PennChart access is a pre-requirement. Data Management; Recruitment; Study Start-Up cosmos, patient data, pennchart, data
- Cost Finder Tool with research rates for both Hospital Billing (HB) and Professional Billing (PB), components of an item/service/procedure. Select at least one entity (HUP, PPMC, PAH OR CCH) prior to searching.Pricing may vary by entity. Ability to search by CPT code (preferred) or procedure name. OCR Applications; Study Start-Up Cost Finder, finance, start up
- Data Safety Monitoring Plan (DSMP) With Guidance This template is intended to be used to develop a data safety monitoring plan. Monitoring DSMP, monitoring, Data Safety Monitoring Plan
- Database Activation Authorization Database Activation Authorization Data Management; Sponsor; Source Documentation edc, sponsor, crf, crms, data management
- Database Lockdown Checklist and CRMS Examples Database Lockdown Checklist and CRMS Examples Data Management; Sponsor; Source Documentation edc, sponsor, crms, source
- 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/ Investigator Site File
- Device Product Information This guidance document assists US IDE, IND, and foreign clinical research device applicant holders in determining what product information is needed and where to place device product information. IDE
- Electronic Data Management Tool This tool is used to assist the determination of what data management tool would be most beneficial for your research study. Budget/ Finance
- Electronic Database Build and Activation Summary Plan Electronic Database Build and Activation Summary Plan Data Management; Sponsor; Source Documentation data management , sponsor, source documentation
- 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 Site File
- IND Enabling Nonclinical Safety Study Work Instructions These work instructions are intended as guidance for personnel who (i) conduct or assist in the conduct of Nonclinical Safety Studies (NSS) to be submitted in support of an IND Application or (ii) have oversight of such activities. Although such studies usually occur prior to the submission of an IND, these work instructions also apply to NSS performed after IND approval and in support of clinical development. If an individual is subject to a FINANCIAL CONFLICT OF INTEREST (FCOI) management plan issued by the Vice Provost for Research, the conditions of the management plan will apply to the conduct of NSS. IND Investigational New Drug (IND)
- IND IDE Exemption Amendment Risk Assessment This form provides instructions, and may be used to document, the Sponsor Investigator’s risk assessment for minor changes to a protocol that has previously received an IND or IDE exemption determination. IND; IDE Modification
- IND-IDE Sponsor Responsibilities Guide Responsibilities of an IND/IDE Sponsor IND; IDE Investigational New Drug (IND), Investigational Device Exemption (IDE)
- Informed Consent Form (ICF) Version Log Tracking log of approvals for Informed Consent Form Regulatory File/ Investigator Site File
- Investigational Product Accountability Study Log Study-level investigational product accountability log (all subjects on one log) Sponsor
- Investigational Product Accountability Subject Log Subject specific investigational product accountability log 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. IDE Institutional Review Board (IRB)
- Monitoring Analysis Template This tool is intended to assist in the planning for monitoring a clinical trial. 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
- Monitoring Close Out Visit Template Monitoring visit report template for the conduct of a close out monitoring visit at the end of a clinical trial. Monitoring; Sponsor; Trial Master File
- Monitoring Findings Template Monitoring Findings Template Monitoring findings, monitoring, site
- Monitoring Visit Report - Sponsor Summary Template for reporting monitoring findings to Sponsor Monitoring
- Monitoring Visit Tracking Log Log used to document monitoring visits over the course of a trial Monitoring
- Note to File Template To be used to create a Note to File which are written to identify a discrepancy or problem in the conduct of the clinical research study. Regulatory File/ Investigator Site File
- On-Site Query Report Form Worksheet for documenting the identification and resolution of queries Monitoring
- Participant Visit Schedule Tool for tracking the proposed and actual dates for subject study visits Study Start-Up
- PennCRMS CRF Guidelines and Tips PennCRMS CRF Guidelines and Tips Data Management; Sponsor; Source Documentation edc, sponsor, crf, crms, data management
- PennChart - Patient Registration Form EMPI If you need your patient/subject setup in PennChart within 24 hours Budget/ Finance
- Pre-Screen Phone Script (Incoming Call) Pre-screen phone script template for incoming calls from potential research participants IND; Recruitment; Regulatory File/ Investigator Site File
- Pre-Screen Phone Script (Outgoing Call) Pre-screen phone script template for outgoing calls to potential research participants Recruitment; Regulatory File/ Investigator Site File
- Principal Investigator (PI) GCP Application Tool Should not replace required Sponsor or Penn training. To be used by experienced CRPs as supplemental training at the time of SIV to ensure PI’s are best positioned to assume their responsibility. Project Management; Regulatory File/ Investigator Site File; Study Start-Up PI, GCP, SIV, Training, Principal Investigator
- 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
- Prospective Reimbursement Analysis/ Medicare Coverage Analysis - Budget Template Template for completing the prospective reimbursement analysis/ medicare coverage analysis and industry sponsored clinical research budget. Budget/ Finance; Regulatory File/ Investigator Site File
- Prospective Study Design with no Investigational Product (IP) Template Link will redirect to the NIH's Protocol Template website. Protocol Templates
- Protocol Adverse Event Log A Log for recording adverse events Regulatory File Adverse Event, Adverse, Event, Log
- Protocol Amendments Log Track versions of the IRB approved Protocol Regulatory File/ Investigator Site File
- Protocol Deviation Log To track all protocol deviations. Regulatory File/ Investigator Site File
- Protocol Training Log Log for documenting the training of research personnel on the research protocol Regulatory File/ Investigator Site File
- RBA Business Admin Approval Tipsheet Tipsheet for the RBA. Shows how to route request for RBN to your BA and OCR Finance for RBN creation Budget/ Finance; OCR Applications; Project Management; Study Start-Up RBA, RBN, Research Billing application, Research Billing number, finance, BA
- RBA New Request Tipsheet Tipsheet with steps on how to submit a new request for a Research Billing Number in the Research Billing Application Budget/ Finance; OCR Applications; Project Management; Study Start-Up RBA, Research Billing Application, Finance, RBN, billing number
- Recording, Assessment, and Reporting of Deviations This document aims to help teams with the recording of deviations and exceptions of an approved protocol, and the reporting requirements to the Penn IRB and Sponsor IND; IDE; Regulatory File/ Investigator Site File; Sponsor
- Recruitment Letter - Physician to Established Patient Template for recruitment letter from an external, referring physician to his/her patient about a research study Recruitment
- Recruitment Letter - Physician to Physician Letter Template Template for recruitment letter from one physician to another about a research study Recruitment
- Recruitment Letter – PI to Patient Template Template for recruitment letter from the Principal Investigator to his/her patient about a research study Recruitment
- Recruitment Letter- Physician to Unknown Potential Subject Template for recruitment letter from a physician to a potential research subject about a research study Recruitment
- Reportable Event Form (Electronic) Form for capturing the details of a Reportable Event for informing a sponsor, manufacturer, or other reporting entity Regulatory File/ Investigator Site 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/ Investigator Site File
- Research Billing Application (RBA) All studies utilizing UPHS services/procedures and/or Imaging Core/Service Center(s) will need to be registered in the Research Billing Application (RBA), regardless of the payor (insurance or research grant). A Research Billing Number (RBN) will be generated for those studies where all or a portion of visits/tests/procedures associated with the research protocol are being billed to the research grant. OCR Applications RBA, billing, research billing application, hospital, services, grant, payor, insurance
- Residual Balance Transfer Request Form Form used to request the residual balance to be transferred from appropriate contracts Budget/ Finance
- Retrospective Study Protocol Template This protocol template is designed to facilitate the creation of a retrospective clinical research protocol. Protocol Templates
- Risk Assessment Template for performing a clinical trial risk assessment for monitoring Monitoring
- Screening and Enrollment Log Document subjects who have been screened and/or enrolled Recruitment; Regulatory File/ Investigator Site File
- Site Guidance for Source Documentation This document contains information about Source Documentation for clinical trials. Regulatory File/ Investigator Site File
- Site Initiation Visit Checklist Checklist for conducting a Site Initiation Visit IND; IDE; Sponsor
- Site Qualification Report Tool for documenting the review and qualification assessment of a site and principal investigator Monitoring; Regulatory File/ Investigator Site File
- Site Visit Log Document the dates of Monitoring Visits Monitoring
- Specimen Preparation Checklist Instructions for collecting, labeling and processing specimens for shipment Regulatory File/ Investigator Site File
- Specimen Shipping Log Log the collection and shipment of specimens Regulatory File/ Investigator Site File
- Sponsor - IDE Investigator List Template for the submission to the FDA-CDHR of the semi-annual list of investigators required by 21CFR 812.150 IDE Investigational Device Exemption (IDE)
- Sponsor Monitoring Plan Guide Guide for developing an IND/IDE sponsor's monitoring plan IND; IDE; Sponsor
- Sponsor Welcome Letter Template for use in negotiating with an industry sponsor. Budget/ Finance
- Study Admin File_Device Template for developing a study administration file or regulatory binder for a device trial Regulatory File/ Investigator Site File
- Study Admin File_Drug Template for developing a study administration file or regulatory binder for a drug trial Regulatory File/ Investigator Site File
- Study Admin File_Social Behavioral Template for developing a study administration file or regulatory binder for a social behavioral study Regulatory File/ Investigator Site File
- 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 Source Documentation
- Subject Eligibility Checklist Template for documenting review of Inclusion and Exclusion criteria Source Documentation
- Testing CRFs Overview in PennCRMS Testing CRFs Overview in PennCRMS Data Management; Sponsor; Source Documentation edc, sponsor, crf, crms, data management
- Trial Master File Template for a Trial Master File Trial Master File Trial Master File (TMF), Sponsor
- Understanding Using an EDC - PennCRMS W Understanding Using an EDC - PennCRMS Workflows Data Management; Sponsor; Source Documentation edc, crms, sponsor, source, crf
- User Acceptance Testing (UAT) Script Template - PennCRMS Template - modification needed | Create User Acceptance Testing (UAT) test scripts for your research study eCRFs | Studies requiring 21CFR11 compliance MUST complete UAT | Specific to UAT in PennCRMS, but can be used for any EDC Data Management; Sponsor; Source Documentation edc, sponsor, crf, crms, data management
- User Acceptance Testing (UAT) Tracker Template Template - modification needed | Track User Acceptance Testing (UAT) progress and completion | Studies requiring 21CFR11 compliance MUST complete UAT | Can be used for any EDC Data Management; Sponsor; Source Documentation edc, sponsor, crf, crms, data management
- W-9 IRS Form (No Form) Federal form used to report income paid to an individual Budget/ Finance
- Zone 2 Core Document Change Control Sponsor checklist to document steps taken for an operationally compliant revision of core documents Sponsor Protocol, Informed Consent Form (ICF), Investigator Brochure (IB)
- eCRF Build and Schedule of Events Tracker Template - PennCRMS Template - modification needed | Building eCRFs and participant schedules/calendars for research studies can be difficult to track. Some eCRFs may have completed validation testing (UAT) while others have yet to be drafted. Study teams can use this document to track the build/testing process. While this template's focus is for building eCRFs in PennCRMS, it can be modified to use for any EDC study build. Data Management; Sponsor; Source Documentation edc, sponsor, crf, crms, data management