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- 3b Forms, Tools, & Templates 21 Description 23 Category(ies) 23 Keyword(s) d c
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- c7 02.04.02 Investigator's Brochure Addendum Log 53 Track versions of the Investigator’s Brochure 63 Trial Documents 25 IB 6 1 1 5
- bf 01.01.01 Work Instructions TMF - PennBox 92 Instructions explaining training requirements, user roles, access, and use of the TMF in the Veeva Vault system 66 Trial Master File 34 Trial Master File 6 1 1 5
- bb 01.01.01 Work Instructions TMF - Veeva 8f Instructions explaining training requirements, user roles, access, and use of the TMF in the PennBox system. 66 Trial Master File 34 Trial Master File 6 1 1 5
- a9 01.02.03 Notice of Disclosure of FCOI 4b Template for written disclosure of FCOI 55 IND; IDE 2a Sponsor 6 1 1 5
- eb 01.02.03 Statement of Financial Interest - Sponsor Team Member a9 Form to be used by Penn Faculty or staff of the Sponsor team to state presence/absence of financial interests for a particular study. 54 Sponsor 3d FCOI, Disclosure, Conflict 6 1 1 5
- a6 01.03.01 DSMB Charter b9 Used to clearly describe how the DSMB will function, including frequency of meetings, data to be reviewed, how safety items will be communicated, etc. 4e DSMB 3f Data safety monitoring board 6 1 1 5
- 9b 01.03.02 DSMB Contact List b8 Used to compile contact information for the DSMB members and their administrative support staff. May be useful as a reference during trial progress. 4e DSMB 3f Data safety monitoring board 6 1 1 5
- a1 01.03.03 DSMB Meeting Minutes a2 Used to document discussions during DSMB meetings. Includes documentation of attendance and disclosure of financial conflicts. 4e DSMB 3f Data safety monitoring board 6 1 1 5
- ab 01.03.03 DSMB Outcome Email Letter d3 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. 4e DSMB 3f Data safety monitoring board 6 1 1 5
- 8e 01.03.03_DSMB_Report a5 Used to provide a summary of trial data to the DSMB. Specific section will differ by study, may be revised based on DSMB request. 4e DSMB 3f Data safety monitoring board 6 1 1 5
- a2 01.03.05 DSMB Qualification Form d9 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. 4e DSMB 3f Data safety monitoring board 6 1 1 5
- ba 01.05.01 Correspondence Log Template 88 Log for documenting correspondence including the date, time, participants, and summary of discussion 69 Project Management 2a Minutes 6 1 1 5
- c0 02.01.01 Investigator Brochure Template 52 Guide for developing an Investigator's Brochure 63 Trial Documents 23 6 1 1 5
- a0 03.01.01 Expanded Access eIND 57 Instructions for submitting an emergency IND request 4c IND 4b Emergency use, Investigational New Drug 6 1 1 5
- a0 03.01.01 Expanded Access sIND 6f Instructions for submitting a (compassionate use) single patient IND request 4c IND 3c Investigational New Drug 6 1 1 5
- b4 03.01.01 IDE Application Template 7a Original Investigational Device Exemption (IDE) template in accordance with 21CFR812.20 4c IDE 3b IDE, Device, application 6 1 1 5
- b4 03.01.01 IND Application Template 6f Template for an application to the FDA for an Investigational New Drug (IND) 4c IND 23 6 1 1 5
- ad 03.01.01 Submitting to the FDA cd 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. 54 Sponsor 50 Regulatory submissions, CDER, CBER, ESG, CDRH 6 1 1 5
- b6 03.01.01 aIDE Application Template 5f Abbreviated Investigational Device Exemption (aIDE) Template 4c IDE 48 abbreviated, IDE, Device, application 6 1 1 5
- b1 03.03.02 IDE Progress Report Template 51 Template for completing an IDE Progress Report 4c IDE 49 Investigational Device Exemption (IDE) 6 1 1 5
- ae 03.03.02 IND Annual Report Template 4f Template for completing an IND Annual Report 4c IND 3c Investigational New Drug 6 1 1 5
- bc 03.03.03 Closing an IND Guide to Sponsor 9d How to discontinue an IND with the FDA. Definitions of the various IND statuses are included below for reference purposes. 4c IND 41 Investigational New Drug (IND) 6 1 1 5
- a4 03.04.02 Regulatory History Log 62 Template for tracking all regulatory submissions of an IND/IDE 55 IND; IDE 2a Sponsor 6 1 1 5
- a6 05.02.01 IB Signature Page 95 This document tracks the Principal Investigator's acknowledgement of an Investigator Brochure for their IND study. 4c IND 6d Investigator Brochure, Principal Investigator, Investigator New Drug (IND) 6 1 1 5
- 9b 05.02.02 PI Signature Page 8f The document to be signed by the Principal Investigator of a study at each revision of the study's protocol. 69 Protocol Templates 58 Principal Investigator, Protocol Amendment, Revision 6 1 1 5
- b8 05.02.06 Significant Deviation Form a8 This is a form to be used by a Sponsor to document the assessment and impact of deviations associated with clinical trial activities. 54 Sponsor 2c Exception 6 1 1 5
- a4 05.02.07 PI Qualification Form 6b Template for documenting the qualifications of a Principal Investigator 54 Sponsor 3e Principal Investigator (PI) 6 1 1 5
- ad 05.02.10 Site Financial Disclosure Form 16f 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.” 54 Sponsor 55 financial interest, financial conflict of interest 6 1 1 5
- bd 05.02.19 IDE Investigator’s Agreement d6 The investigator agreement of compliance to all requirements of the investigational plan, IDE regulations, and other applicable regulations of the FDA for investigational devices. 4c IDE 34 Statement, Device 6 1 1 5
- cb 07.01.01 Work Instructions - Pharmacovigilance 119 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. 54 Sponsor 32 Sponsor, Safety 6 1 1 5
- 93 07.02.02 SAE Form 8d Form used to document an SAE that occurs in a trial and to report the relevant information to the sponsor. 63 Trial Documents 3e Serious Adverse Event (SAE) 6 1 1 5
- b5 09.01.01 Device Manufacturer Evaluation 132 To demonstrate oversight of the manufacturer of investigational device, this form should be completed prior to the submission of the application (trial start) and periodically throughout the duration of the trial (at least annually) in order to evaluate the manufacturer. 54 Sponsor 72 Investigational Product Manufacturer Qualification/Requalification, Device, IDE 6 1 1 5
- a7 09.01.01 GLP Qualification Guide 92 Guide to ensuring vendors providing investigational product are qualified and follow Good Laboratory Practices 6b Third Party/ Vendors 23 6 1 1 5
- b6 09.01.01 IND Manufacturer Requalification 132 To demonstrate oversight of the manufacturer of investigational device, this form should be completed prior to the submission of the application (trial start) and periodically throughout the duration of the trial (at least annually) in order to evaluate the manufacturer. 54 Sponsor 4a IND, Drug, Manufacturer Requalification 6 1 1 5
- a7 09.02.03 Transfer of Obligations 66 Guide to transferring IND/IDE sponsor obligations to another party 55 IND; IDE 29 Vendor 6 1 1 5
- b7 21 CFR Part 11 for EMR 70 Memo- Penn Medicine Electronic Health Records in Support of Clinical Research 7d Communication; Study Start-Up 56 part 11, 21 cfr part 11, EMR, compliance, pennchart 6 1 1 5
- b3 Abbreviated IDE Requirements (FDA) 5d Details of the Sponsor requirements for an abbreviated IDE 4c IDE 56 Abbreviated Investigational Device Exemption (aIDE) 6 1 1 5
- 4e CLIA, CAP, Lab References, Lab Director’s CV 1c 76 To obtain documents email: psom-ocrcompliance@pobox.upenn.edu c ba Regulatory File/ Investigator Site File; Source Documentation 4e CLIA, CAP, Lab References, lab director, CV 6 1 1 5
- 6c CRSPR Email Listserve 12d 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. 65 OCR Applications 59 CRSPR, listserve, application, email, portal, registry 6 1 1 5
- 95 Case Report Form Amendments Log 55 Track Case Report Form (CRF) versions and changes 8f Regulatory File/ Investigator Site File 26 CRF 6 1 1 5
- b9 Clinical Research Resource Feasibility Assessment 23 62 Budget/ Finance 23 6 1 1 5
- a5 Clinical Trial Protocol Template d1 This protocol template is designed to help research teams develop a clinical trial protocol that includes an investigational intervention (drug, biologic, vaccine or device). 69 Protocol Templates 23 6 1 1 5
- b2 Close Out Visit Checklist - Investigator 48 Checklist for closing out a protocol 5a Monitoring 23 6 1 1 5
- be Close Out Visit Checklist- Sponsor Investigator 6c Checklist for closing out a protocol by a Sponsor or Sponsor Investigator 5a Monitoring 23 6 1 1 5
- 9e Closing IDE Guide to Sponsor 9e How to discontinue an IDE with the FDA. Definitions of the various IDE statuses are included below for reference purposes. 4c IDE 53 Investigational Device Exemption (IDE), Closeout 6 1 1 5
- 96 Cosmos Access Form a3 Complete this form to request access to EPIC/PennChart's COSMOS network for patient data. PennChart access is a pre-requirement. 99 Data Management; Recruitment; Study Start-Up 48 cosmos, patient data, pennchart, data 6 1 1 5
- 67 Cost Finder 141 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. 82 OCR Applications; Study Start-Up 41 Cost Finder, finance, start up 6 1 1 5
- bb Data Management Plan Creation Guidance bb A Data Management Plan (DMP) comprehensively documents data and its handling from definition, collection, and processing to final archival or disposal. 63 Data Management 33 Data Management 6 1 1 5
- d4 Data Safety Monitoring Plan (DSMP) With Guidance 72 This template is intended to be used to develop a data safety monitoring plan. 5a Monitoring 50 DSMP, monitoring, Data Safety Monitoring Plan 6 1 1 5
- b4 Database Activation Authorization 44 Database Activation Authorization 9f Data Management; Sponsor; Source Documentation 4b edc, sponsor, crf, crms, data management 6 1 1 5
- cc Database Lockdown Checklist and CRMS Examples 50 Database Lockdown Checklist and CRMS Examples 9f Data Management; Sponsor; Source Documentation 3d edc, sponsor, crms, source 6 1 1 5
- b3 Delegation of Responsibility and Signature Log ce 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. 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 99 Device Product Information e7 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. 4c IDE 23 6 1 1 5
- a2 Electronic Data Management Tool a0 This tool is used to assist the determination of what data management tool would be most beneficial for your research study. 62 Budget/ Finance 23 6 1 1 5
- dc Electronic Database Build and Activation Summary Plan 58 Electronic Database Build and Activation Summary Plan 9f Data Management; Sponsor; Source Documentation 53 data management , sponsor, source documentation 6 1 1 5
- 98 ICH GCP Essential Documents 92 Table of regulatory files that should be maintained by the PI and Sponsor throughout a clinical research study 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- d5 IND Enabling Nonclinical Safety Study Work Instructions 289 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. 4c IND 41 Investigational New Drug (IND) 6 1 1 5
- be IND IDE Exemption Amendment Risk Assessment f1 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. 55 IND; IDE 2f Modification 6 1 1 5
- b6 IND-IDE Sponsor Responsibilities Guide 49 Responsibilities of an IND/IDE Sponsor 55 IND; IDE 69 Investigational New Drug (IND), Investigational Device Exemption (IDE) 6 1 1 5
- 9c Informed Consent Form (ICF) Version Log 56 Tracking log of approvals for Informed Consent Form 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- b0 Investigational Product Accountability Study Log 74 Study-level investigational product accountability log (all subjects on one log) 54 Sponsor 23 6 1 1 5
- b4 Investigational Product Accountability Subject Log 5f Subject specific investigational product accountability log 54 Sponsor 23 6 1 1 5
- a7 Medicaid Attestation Form 84 Purpose is to confirm that research-related services are not inappropriately billed to Medicaid. ce Budget/ Finance; Regulatory File/ Investigator Site File; Trial Documents 6d medicaid, attestation, billing, study related, compliance, patient billing 6 1 1 5
- 84 Memo from Penn IRB a3 Memo from Penn IRB regarding the IRB not disclosing names of its members. This is a necessary component of the IDE application. 4c IDE 43 Institutional Review Board (IRB) 6 1 1 5
- 9f Monitoring Analysis Template 74 This tool is intended to assist in the planning for monitoring a clinical trial. 5a Monitoring 23 6 1 1 5
- a7 Monitoring Assessment Guidance Document b8 This document is designed to assist study teams with completing an appropriate monitoring summary for the Penn IRB at the time of continuing review. 5a Monitoring 23 6 1 1 5
- ad Monitoring Close Out Visit Template 94 Monitoring visit report template for the conduct of a close out monitoring visit at the end of a clinical trial. 8e Monitoring; Sponsor; Trial Master File 23 6 1 1 5
- aa Monitoring Findings Template 3f Monitoring Findings Template 5a Monitoring 3d findings, monitoring, site 6 1 1 5
- cc Monitoring Visit Report - Sponsor Summary 59 Template for reporting monitoring findings to Sponsor 5a Monitoring 23 6 1 1 5
- b9 Monitoring Visit Tracking Log 64 Log used to document monitoring visits over the course of a trial 5a Monitoring 23 6 1 1 5
- 88 Note to File Template ad 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. 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 96 On-Site Query Report Form 6a Worksheet for documenting the identification and resolution of queries 5a Monitoring 23 6 1 1 5
- 99 Participant Visit Schedule 6c Tool for tracking the proposed and actual dates for subject study visits 60 Study Start-Up 23 6 1 1 5
- b2 PennCRMS CRF Guidelines and Tips 43 PennCRMS CRF Guidelines and Tips 9f Data Management; Sponsor; Source Documentation 4b edc, sponsor, crf, crms, data management 6 1 1 5
- a9 PennChart - Patient Registration Form EMPI 67 If you need your patient/subject setup in PennChart within 24 hours 62 Budget/ Finance 23 6 1 1 5
- aa Pre-Screen Phone Script (Incoming Call) 7c Pre-screen phone script template for incoming calls from potential research participants b1 IND; Recruitment; Regulatory File/ Investigator Site File 23 6 1 1 5
- aa Pre-Screen Phone Script (Outgoing Call) 7a Pre-screen phone script template for outgoing calls to potential research participants a8 Recruitment; Regulatory File/ Investigator Site File 23 6 1 1 5
- 9c Pre-Sub Qsub Template 9f Template for requesting a formal meeting or written feedback from the FDA to discuss applications related to medical devices 4c IDE 58 Pre-Sub, Qsub, Investigational Device Exemption (IDE) 6 1 1 5
- 8e Principal Investigator (PI) GCP Application Tool e9 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. d2 Project Management; Regulatory File/ Investigator Site File; Study Start-Up 51 PI, GCP, SIV, Training, Principal Investigator 6 1 1 5
- 9b Principal Investigator Compliance Assessment (PICA) fb 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. 5a Monitoring 23 6 1 1 5
- d8 Prospective Reimbursement Analysis/ Medicare Coverage Analysis - Budget Template af Template for completing the prospective reimbursement analysis/ medicare coverage analysis and industry sponsored clinical research budget. ae Budget/ Finance; Regulatory File/ Investigator Site File 23 6 1 1 5
- d2 Prospective Study Design with no Investigational Product (IP) Template 5e Link will redirect to the NIH's Protocol Template website. 69 Protocol Templates 23 6 1 1 5
- 8f Protocol Adverse Event Log 45 A Log for recording adverse events 63 Regulatory File 45 Adverse Event, Adverse, Event, Log 6 1 1 5
- 93 Protocol Amendments Log 4f Track versions of the IRB approved Protocol 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 92 Protocol Deviation Log 45 To track all protocol deviations. 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 8f Protocol Training Log 73 Log for documenting the training of research personnel on the research protocol 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- a1 RBA Business Admin Approval Tipsheet 87 Tipsheet for the RBA. Shows how to route request for RBN to your BA and OCR Finance for RBN creation c7 Budget/ Finance; OCR Applications; Project Management; Study Start-Up 70 RBA, RBN, Research Billing application, Research Billing number, finance, BA 6 1 1 5
- 95 RBA New Request Tipsheet 97 Tipsheet with steps on how to submit a new request for a Research Billing Number in the Research Billing Application c7 Budget/ Finance; OCR Applications; Project Management; Study Start-Up 62 RBA, Research Billing Application, Finance, RBN, billing number 6 1 1 5
- bd Recording, Assessment, and Reporting of Deviations c8 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 b2 IND; IDE; Regulatory File/ Investigator Site File; Sponsor 23 6 1 1 5
- cc Recruitment Letter - Physician to Established Patient 93 Template for recruitment letter from an external, referring physician to his/her patient about a research study 5c Recruitment 23 6 1 1 5
- d1 Recruitment Letter - Physician to Physician Letter Template 78 Template for recruitment letter from one physician to another about a research study 5c Recruitment 23 6 1 1 5
- b8 Recruitment Letter – PI to Patient Template 8d Template for recruitment letter from the Principal Investigator to his/her patient about a research study 5c Recruitment 23 6 1 1 5
- da Recruitment Letter- Physician to Unknown Potential Subject 8b Template for recruitment letter from a physician to a potential research subject about a research study 5c Recruitment 23 6 1 1 5
- a7 Reportable Event Form (Electronic) 99 Form for capturing the details of a Reportable Event for informing a sponsor, manufacturer, or other reporting entity 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 9d Reportable Event Form (Paper) 99 Form for capturing the details of a Reportable Event for informing a sponsor, manufacturer, or other reporting entity 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- df Research Billing Application (RBA) 1b8 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. 65 OCR Applications 7a RBA, billing, research billing application, hospital, services, grant, payor, insurance 6 1 1 5
- a9 Residual Balance Transfer Request Form 7a Form used to request the residual balance to be transferred from appropriate contracts 62 Budget/ Finance 23 6 1 1 5
- aa Retrospective Study Protocol Template 90 This protocol template is designed to facilitate the creation of a retrospective clinical research protocol. 69 Protocol Templates 23 6 1 1 5
- 91 Risk Assessment 6b Template for performing a clinical trial risk assessment for monitoring 5a Monitoring 23 6 1 1 5
- 99 Screening and Enrollment Log 5c Document subjects who have been screened and/or enrolled a8 Recruitment; Regulatory File/ Investigator Site File 23 6 1 1 5
- ab Site Guidance for Source Documentation 76 This document contains information about Source Documentation for clinical trials. 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 9b Site Initiation Visit Checklist 54 Checklist for conducting a Site Initiation Visit 66 IND; IDE; Sponsor 23 6 1 1 5
- a2 Site Qualification Report 85 Tool for documenting the review and qualification assessment of a site and principal investigator a6 Monitoring; Regulatory File/ Investigator Site File 23 6 1 1 5
- 81 Site Visit Log 4b Document the dates of Monitoring Visits 5a Monitoring 23 6 1 1 5
- a1 Specimen Preparation Checklist 6f Instructions for collecting, labeling and processing specimens for shipment 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 8f Specimen Shipping Log 50 Log the collection and shipment of specimens 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- a2 Sponsor - IDE Investigator List 92 Template for the submission to the FDA-CDHR of the semi-annual list of investigators required by 21CFR 812.150 4c IDE 49 Investigational Device Exemption (IDE) 6 1 1 5
- 9b Sponsor Monitoring Plan Guide 5d Guide for developing an IND/IDE sponsor's monitoring plan 66 IND; IDE; Sponsor 23 6 1 1 5
- 92 Sponsor Welcome Letter 5d Template for use in negotiating with an industry sponsor. 62 Budget/ Finance 23 6 1 1 5
- a6 Study Admin File_Device 7f Template for developing a study administration file or regulatory binder for a device trial 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 9b Study Admin File_Drug 7d Template for developing a study administration file or regulatory binder for a drug trial 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- bc Study Admin File_Social Behavioral 8a Template for developing a study administration file or regulatory binder for a social behavioral study 8f Regulatory File/ Investigator Site File 23 6 1 1 5
- 9d Study Feasibility Assessment 90 Tool for assessing the resources, recruitment potential, and logistical considerations of a particular study 60 Study Start-Up 23 6 1 1 5
- a1 Subject Contact Information Sheet 55 Collect contact information for research subjects 6e Source Documentation 23 6 1 1 5
- a7 Subject Eligibility Checklist 67 Template for documenting review of Inclusion and Exclusion criteria 6e Source Documentation 23 6 1 1 5
- b4 Testing CRFs Overview in PennCRMS 44 Testing CRFs Overview in PennCRMS 9f Data Management; Sponsor; Source Documentation 4b edc, sponsor, crf, crms, data management 6 1 1 5
- 84 Trial Master File 44 Template for a Trial Master File 66 Trial Master File 43 Trial Master File (TMF), Sponsor 6 1 1 5
- c6 Understanding Using an EDC - PennCRMS W 52 Understanding Using an EDC - PennCRMS Workflows 9f Data Management; Sponsor; Source Documentation 42 edc, crms, sponsor, source, crf 6 1 1 5
- ca User Acceptance Testing (UAT) Script Template - PennCRMS 107 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 9f Data Management; Sponsor; Source Documentation 4b edc, sponsor, crf, crms, data management 6 1 1 5
- b4 User Acceptance Testing (UAT) Tracker Template d2 Template - modification needed | Track User Acceptance Testing (UAT) progress and completion | Studies requiring 21CFR11 compliance MUST complete UAT | Can be used for any EDC 9f Data Management; Sponsor; Source Documentation 4b edc, sponsor, crf, crms, data management 6 1 1 5
- 36 W-9 IRS Form (No Form) 5c Federal form used to report income paid to an individual 62 Budget/ Finance 23 6 1 1 5
- b1 Zone 2 Core Document Change Control 86 Sponsor checklist to document steps taken for an operationally compliant revision of core documents 54 Sponsor 64 Protocol, Informed Consent Form (ICF), Investigator Brochure (IB) 6 1 1 5
- d3 eCRF Build and Schedule of Events Tracker Template - PennCRMS 1bb 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. 9f Data Management; Sponsor; Source Documentation 4b edc, sponsor, crf, crms, data management 6 12