Guidelines, Procedures & Training
Drexel University’s Office of Research and Innovation (ORI) is committed to ensuring a culture of compliance through the responsible conduct of research consistent with best practices for quality, integrity, and regulatory requirements of research conducted by Drexel University.
Notice: We are in the process of converting all Office of Research & Innovation Standard Operating Procedures (SOPs) into the catalog below. Currently, you’ll find general ORI, Good Clinical Practice (GCP), and Institutional Animal Care and Use Committee (IACUC) procedures and forms available here. The remaining components (e.g., COI, and IRB) will continue to have specific policies and procedures available on their respective sites for time being. We are actively working to expand this resource to include additional teams soon. Stay tuned for updates!
Looking for training? Visit our ORI Informational and Training Resource Library
Compliance Documents
Search for an available document by category, title, or keyword below.
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| Name | Keywords | Link | ||
|---|---|---|---|---|
| Animal Care and Use | 2025/02/12 | ACU-001: IACUC Procedures Manual The purpose of this document is to assist and educate Drexel University faculty, students and staff in the preparation and submission of protocols involving live vertebrate animals for review by the IACUC and to provide procedures for the subsequent conduct of those protocols. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate | IACUC Procedures Manual [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-002: IACUC Member Training and Continuous Education This document provides an overview of the training provided to new IACUC members. |
IACUC, Member, Training | IACUC Member Training and Continuing Education Practices [PDF] |
| Animal Care and Use | 2023/05/22 | ACU-003: IACUC Policy for Animal Number Request The purpose of this document is to provide a clear and consistent animal number approval policy. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate | IACUC Policy for Animal Number Request [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-004: IACUC Designated Member Review (DMR) Procedures This procedure defines Designated Member Review (DMR) at Drexel University. |
IACUC, Member, Review | IACUC DMR Procedures [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-005: Wildlife and Field Studies – Standard Operating Procedures The purpose of this document is to ensure that field studies utilizing wildlife are performed according to state, Federal, and International laws and regulations and to ensure for the proper care and use of animals used in these studies. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate, Wildlife | Wildlife and Field Studies Procedures [PDF] |
| Animal Care and Use | 2024/04/24 | ACU-006: Assigning Pain and Distress Categories on IACUC Protocols - Standard Operating Procedures The purpose of this procedure is to assist Principal Investigators in protocol preparation by providing guidelines for assigning research and teaching animals into appropriate pain and distress categories. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Pain, Painful, Distress, Distressing, Unalleviated, Alleviated, Category C, Category D, Category E, Endpoint, Alternatives, Surgery | Assigning Pain and Distress Categories on IACUC Protocols [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-007: Investigating Animal Welfare Concerns & Noncompliant Activities – Standard Operating Procedures The purpose of these procedures is to describe the process adopted by the Drexel University IACUC to review, investigate, and report animal welfare concerns. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate, Welfare, Noncompliance, Adverse, Concern | Investigating Animal Welfare Concerns & Noncompliant Activities [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-008: Veterinary Verification and Consultation (VVC) – Standard Operating Procedures This procedure allows for certain significant changes to be preapproved by the IACUC and verified by the institution’s Attending Veterinarian. |
IACUC, Member, Review | Veterinary Verification and Consultation (VVC) [PDF] |
| Animal Care and Use | 2024/04/09 | ACU-201: Food and Water Restriction in Research Rodents Procedures The purpose of this procedure is to guide principal investigators and their staff in withholding feed and/or water from laboratory rodents. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate | Food and Water Restriction in Research Rodents Procedures [PDF] |
| Animal Care and Use | 2023/05/22 | ACU-202: IACUC Rodent Breeding Policy This document provides information for the proper maintenance of rodent breeding colonies, specifically mice (Musmusculus) and rats (Rattus rattus). |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Breeding, Breed, Colony | IACUC Rodent Breeding Policy [PDF] |
| Animal Care and Use | 2024/11/18 | ACU-203: Animal Enrichment The purpose of this procedure is to ensure that all animals housed in the animal facility receive appropriate environmental enrichment. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Swine, Pig, Rabbit, Vertebrate, Mammal, Enrichment | Animal Enrichment [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-204: Transport of Animals The purpose of this procedure is to ensure that animal transport outside of ULAR animal facilities is performed in a manner that is safe for the animals and healthy for the personnel using the vehicle. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate, Transport, Transportation | Transport of Animals [PDF] |
| Animal Care and Use | 2024/04/24 | ACU-205: Sterilizing Surgical Materials Used on Animals This document defines the methods and documentation required for sterilizing surgical instruments and materials. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Sterilize, Sterile, Autoclave, Chemical, Steam, Gas, Surgery, Aseptic, Bead sterilizer, Re-sterilization, Record keeping, Surgical instruments/materials | Sterilizing Surgical Materials Used on Animals [PDF] |
| Animal Care and Use | 2024/06/26 | ACU-206: Animal Blood Collection Site – Standard Operating Procedures The purpose of this procedure is to ensure that distress to the animal is minimized during blood collection. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Swine, Pig, Rabbit, Sample, Blood | Animal Blood Collection Site [PDF] |
| Animal Care and Use | 2024/06/26 | ACU-207: Animal Blood Volume Sampling – Standard Operating Procedures This document specifies blood sampling volumes which can be obtained without having an adverse effect on research animals. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Swine, Pig, Rabbit, Sample, Blood | Animal Blood Volume Sampling [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-208: Dosing Volume – Standard Operating Procedures This document defines appropriate dosing volumes for the various laboratory animal species. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Swine, Pig, Rabbit, Dose | Dosing Volume [PDF] |
| Animal Care and Use | 2024/06/26 | ACU-209: Euthanasia The purpose of this procedure is to assure compliant and humane methods of euthanasia. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Swine, Pig, Amphibian, Frog, Fish, Rabbits, Euthanasia | Euthanasia [PDF] |
| Animal Care and Use | 2024/04/24 | ACU-210: Tissue Collection Procedures for Rodent Genotyping This document provides guidance to the research community on the selection and execution of methods used to obtain mouse or rat tissue for genotyping purposes. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Tissue, Collection, Genotype, Ear Biopsy, Pinna/Pinnea, Notching, Punch, Tail Biopsy, Identification | Tissue Collection Procedures for Rodent Genotyping [PDF] |
| Animal Care and Use | 2024/04/09 | ACU-211: Non-Pharmaceutical Grade Agents or Mixtures of Pharmaceuticals (Cocktails) Use Procedures The purpose of this procedure is to ensure the use of non-pharmaceutical agents, mixtures of pharmaceuticals (cocktails) and nondrugs administered to animals by the parenteral route are of the appropriate chemical purity and quality and in the appropriate solution or compound, to ensure stability, safety, and efficacy. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Mammal, Vertebrate, non-pharmaceuticals, rDNA, compounds | No-Pharmaceutical Grade Agents or Mixtures of Pharmaceuticals (Cocktails) Use Procedures [PDF] |
| Animal Care and Use | 2024/05/22 | ACU-212: Non-Rodent Mammal Surgical and Post-Operative Care This document describes the proper procedures for surgery, including pre-operative and postoperative care of non-rodent mammals (such as rabbits, pigs). |
IACUC, Animals, Surgery, Post-operative, Recordkeeping, Survival, Non-survival, Anesthesia, Aseptic, Pig, Swine, Rabbit, Mammal, Vertebrate | Non-Rodent Mammal Surgical and Post-Operative Care [PDF] |
| Animal Care and Use | 2024/05/22 | ACU-212: Non-Rodent Mammal Surgery Record Log This form accompanies the Non-Rodent Mammal Surgical and Post-Operative Care procedure and should be completed for all non-rodent mammal surgeries. |
IACUC, Animals, Surgery, Post-operative, Recordkeeping, Survival, Non-survival, Anesthesia, Aseptic, Pig, Swine, Rabbit, Mammal, Form, Vertebrate | LOG - Non-Rodent Mammal Surgery Record Log [PDF] |
| Animal Care and Use | 2024/11/18 | ACU-213: Surgery and Postsurgical Care of Rodents The purpose of this procedure is to ensure that appropriate provisions have been made for preoperative and postoperative care of rodents. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Survival, Non-survival, Post-operative, Recordkeeping, Anesthesia, Aseptic | Surgery and Postsurgical Care of Rodents [PDF] |
| Animal Care and Use | 2024/11/18 | ACU 213: Rodent Surgery Record Log This form accompanies the Surgery and Postsurgical Care of Rodents procedure and should be completed for all rodent surgeries. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Form, Recordkeeping | LOG - Rodent Surgery Record Log [PDF] |
| Animal Care and Use | 2024/05/22 | ACU-214: Expired Drugs and Medical Materials This document provides guidance to principal investigators and their staff regarding the expiration and disposal of expired drugs and medical materials |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Drugs, Medical Materials, Expiration, Drug Inventory, Drug Disposal, Recordkeeping, Fluids, Saline, Compounds, Dilutions, Recordkeeping | Expired Drugs and Medical Materials [PDF] |
| Animal Care and Use | 2024/06/26 | ACU-215: Physical Restraint The purpose of this procedure is to assure appropriate IACUC oversight of physical restraint of animals and to ensure humane care and use of animals when such restraint is employed. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Prolonged, Mammal, Vertebrate | Physical Restraint [PDF] |
| Animal Care and Use | 2023/06/14 | ACU-216: IACUC Policy on the Use of Image or Sound Recordings in Animal Facilities, Research or Teaching Laboratories The purpose of this document is to protect the confidentiality of faculty research, provide a minimally disruptive atmosphere for animal residents and guard against the misinterpretation of appropriate and humane policies and procedures. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, image, recording | IACUC Policy on the Use of Image or Sound Recordings in Animal Facilities, Research or Teaching Laboratories [PDF] |
| Animal Care and Use | 2024/11/18 | ACU-217: Sanitizing Equipment for Use with Research Animals This document defines the methods and documents required for sanitization of equipment, instruments, and the experimental environment for use in animal research by the proper use of cleaning and disinfectants. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Cleaning, Disinfection, Sterilization, Surgery, Behavioral, Carts, Transports, Sanitization | Sanitizing Equipment for Use with Research Animals [PDF] |
| Animal Care and Use | 2025/02/12 | ACU-218: Tumor-Bearing Animal The purpose of this procedure is to identify and resolve animal welfare issues related to experimentally-induced tumors in animals. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Tumor, Endpoint, Mammal, Vertebrate | Tumor-Bearing Animal [PDF] |
| Animal Care and Use | 2024/09/17 | ACU-219: Drug Formulary of Anesthetic and Analgesic Agents for Laboratory Animals This document includes the IACUC drug formulary of anesthetic and analgesic agents for laboratory animals. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Pig, Swine, Rabbit, Frog, fish, amphibian, Mammal, Vertebrate | Drug Formulary of Anesthetic and Analgesic Agents for Laboratory Animals [PDF] |
| Animal Care and Use | 2023/12/04 | ACU-401: FORM - IACUC Change of Principal Investigator This form should be used to request a change of principal investigator on IACUC protocols. |
IACUC, animals, Rodents, Mice, Mouse, Rats, Form, Amendment | FORM - IACUC Change of Principal Investigator [PDF] |
| Animal Care and Use | 2023/12/04 | ACU-402: FORM - IACUC Protocol Close-Out Request This form should be used to request closure of an IACUC protocol. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Form | FORM - IACUC Protocol Close-Out Request [PDF] |
| Animal Care and Use | 2012/05/29 | ACU-001: LETTER - Animal Facility Requirements for Non-Employees This form should be completed by all contractors, vendor, students, and visitors working in areas containing laboratory research animals for the purpose of documenting the communication of hazards associated with laboratory research animals to these individuals. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, visitor, Form, health | LETTER - Animal Facility Requirements for Non-Employees [PDF] |
| Animal Care and Use | 2019/08/13 | ACU-202: TEMPLATE - Breeding Card Template This template should be completed when breeding research animals. |
IACUC, Animals, Rodents, Mice, Mouse, Rats, Template | TEMPLATE - Breeding Card Template [PDF] |
| ORI | 2023/11/01 | ORI-002: Principal Investigator Eligibility and Responsibilities This document outlines the eligibility, responsibilities, and expectations for Principal Investigator (PI) engaged in research activities, funded programs, projects, or related activities under the oversight of Drexel University’s Office of Research and Innovation (ORI). |
HRPP, IRB, IACUC, Faculty, PI, Responsibility, Department, Eligibility | Principal Investigator Eligibility and Responsibilities [PDF] |
| ORI | 2023/10/25 | ORI-002: FAQ - Frequently Asked Questions - PrincipaI Investigator Eligibility and Responsibilities These are the frequently asked questions accompanying the release of the Principal Investigator Eligibility and Responsibilities procedures. |
HRPP, IRB, IACUC, Faculty, FAQ, Questions, PI, Responsibility, Department, Eligibility | FAQ - PI Eligibility and Responsibilities [PDF] |
| ORI | 2023/11/01 | ORI-002: FORM - Principal Investigator and Faculty Mentor Exception Form This form accompanies the Principal Investigator Eligibility and Responsibilities procedures and should be used to request an exception to the eligibility requirements outlined within the procedure document. |
HRPP, IRB, IACUC, Faculty, Form, Exception, PI, Responsibility, Department, Eligibility | FORM - PI Eligibility and Responsibilities Exception Form [PDF] |
| ORI | 2023/11/01 | ORI-003: Investigator Guidance – Departing Faculty Checklist This guidance outlines the procedures related to the departure of faculty members who are involved in research activities from Drexel University. |
HRPP, IRB, IACUC, Faculty, Leave, Leaving, Transfer, PI, Principal Investigator, Department | Departing Faculty Checklist and Guidance [PDF] |
| ORI | 2025/02/11 | ORI-004: Drexel Research Agent Eligibility and Responsibilities The purpose of this procedure is to define and outline the role of the Drexel Research Agent |
HRPP, IRB, IACUC, Faculty, Staff, Volunteers, NEA, Visiting, Responsibility, Department | Research Agent Eligibility and Responsibilities [PDF] |
| ORI | 2024/04/17 | ORI-004: FAQ - Frequently Asked Questions - ORI Research Agent Eligibility and Responsibilities These are the frequently asked questions accompanying the release of the Research Agent Eligibility and Responsibilities procedures. |
HRPP, IRB, IACUC, Faculty, Staff, Volunteers, NEA, Visiting, Responsibility, Department, FAQ, Questions | FAQ - Research Agent Eligibility and Responsibilities [PDF] |
| ORI | 2024/12/19 | ORI-004: FORM - Research Agent Exception Form and Investigator Agreement This form accompanies the Research Agent Eligibility and Responsibilities procedures and should be used to request an exception to the eligibility requirements outlined within the procedure document. |
HRPP, IRB, IACUC, Faculty, Staff, Volunteers, NEA, Visiting, Responsibility, Department, Form, Exception, IIA | FORM - Research Agent Eligibility Exception Form [PDF] |
| ORI | 2025/02/11 | ORI-006: Addressing Harassment and Discrimination in Research – Standard Operating Procedures The purpose of this procedure is to define and outline Drexel University’s Office of Research and Innovation’s (ORI) response to allegations or concerns related to harassment, bullying, retaliation, hostile working conditions, or other unsafe environments. |
HRPP, IRB, IACUC, Faculty, Staff, Volunteers, PI, Principal Investigator, Reporting Requirements, NIH, NSF, NASA, AOR | Addressing Harassment and Discrimination in Research [PDF] |
| ORI | 2024/12/20 | ORI-006: TEMPLATE - Conference Safety Plan Template This template accompanies the procedure for Addressing Harassment and Discrimination in Research and should be used for the establishment of safety plans as required by sponsors, funders, or as applicable. |
HRPP, IRB, IACUC, Faculty, Staff, PI, Principal Investigator, Training, Volunteers, Template, NIH, NSF | TEMPLATE - Conference Safety Plan Template [DOC] |
| ORI | 2024/12/12 | ORI-006: TRAINING VIDEO - ORI-006 Addressing Harassment and Discrimination in Research Guidelines and Procedures Update This training video accompanies the procedure for Addressing Harassment and Discrimination in Research. |
HRPP, IRB, IACUC, Faculty, Staff, Volunteers, PI, Principal Investigator, Training, NIH, NSF, Recording | Training Video - Addressing Harassment and Discrimination in Research |
| ORI | 2024/12/02 | ORI-006: LETTER - Institutional Letter for Applicable NIH Training Grants This institutional letter accompanies the procedure for Addressing Harassment and Discrimination in Research applicable to NIH training grants. |
HRPP, IRB, IACUC, Faculty, Staff, Letter, NIH, Training Award | LETTER - Institutional Letter for Applicable NIH Training Grants [PDF] |
| ORI | 2023/02/10 | ORI-101: Procedures for Research Blood Draws These procedures support the University’s efforts to protect human subjects and Drexel University Agents while minimizing institutional risk in conducting blood draws for research purposes. |
Finger stick, Intravenous, Phlebotomy, Venipuncture, Training, Requirements | Procedures for Research Blood Draws [PDF] |
| ORI | 2023/02/10 | ORI 101: FORM - Drexel University ORI-Research Phlebotomy Training Request Form This form accompanies the Procedures for Research Blood Draws and should be used to request phlebotomy training. |
Finger stick, Intravenous, Phlebotomy, Venipuncture, Training | Phlebotomy Training Request Form |
| ORI | 2023/02/10 | ORI 101: FAQ - Frequently Asked Questions - Research Blood Draws These are the frequently asked questions accompanying the release of the Procedures for Research Blood Draws. |
Finger stick, Intravenous, Phlebotomy, Venipuncture, FAQ, Questions, Training, Requirements | FAQ - Research Blood Draws [PDF] |
| ORI | 2023/02/10 | ORI-101: PRESENTATION - Procedures for Research Blood Draws This presentation accompanies the Procedures for Research Blood Draws. |
Finger stick, Intravenous, Phlebotomy, Venipuncture, Presentation, Training, Requirements | Presentation - Procedures for Research Blood Draws [PDF] |
| ORI | 2023/09/01 | ORI-201: Community Advisory Board Member - Guideline These guidelines establish best practices for selection, recruitment, and establishment of payment mechanisms and agreement types. |
HRPP, IRB, CAB | Community Advisory Board Member Guideline [PDF] |
| ORI | 2023/11/01 | ORI-201: FORM - Community Advisory Board Member Attestation Form This form accompanies the Community Advisory Board Member guidelines and should be used to... |
HRPP, IRB, CAB, Form | FORM - Community Advisory Board Member Attestation Form [DOC] |
| ORI | 2023/11/01 | ORI-201: FLOWCHART - Community Advisory Board Payment Mechanism and Agreement Algorithm This flowchart accompanies the Community Advisory Board Member Guidelines. |
HRPP, IRB, CAB, Flowchart | Flowchart - Community Advisory Board Payment Mechanism and Agreement Algorithm [PDF] |
| ORI | 2023/11/01 | ORI-201: FORM - Request to Use JP Morgan Concourse This form accompanies the Community Advisory Board Member Guidelines and should be used to request to use the JP Morgan Concourse digital payment platform to pay research participants. |
HRPP, IRB, CAB, Form | FORM - Request to Use JP Morgan Concourse [PDF] |
| ORI | 2023/08/23 | ORI-201: PRESENTATION - Community Advisory Board Member - Payment Update This presentation accompanies the Community Advisory Board Member guidelines. |
HRPP, IRB, CAB, Presentation | Presentation - Community Advisory Board Member - Payment Update [PDF] |
| ORI | 2025/01/24 | ORI-613 Guidelines for Site Initiation This guidance describes the activities completed by the study personnel before, during and after site initiation or site initiation visit (SIV) to ensure that all site personnel are properly trained, the study materials and documentation are in place, and the site is ready to start the clinical research study. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Start-up | ORI-613 Guidelines for Site Initiation [PDF] |
| ORI | 2025/01/24 | ORI-613 CHECKLIST – Site Initiation Checklist This is a supplemental checklist to the Guidelines for Site Initiation that can be used to aid in site initiation activities. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Start-up, Checklist | ORI-613 CHECKLIST – Site Initiation Checklist [DOC] |
| ORI | 2025/01/24 | ORI-615 Maintenance of Regulatory Files This guideline outlines the process for the establishment, management and retention of essential documents and regulatory files that are required for clinical research in compliance with good clinical practice (GCP) guidelines. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Essential Documents, ISF, Investigator Site Files, Binder | ORI-615 Maintenance of Regulatory Files [PDF] |
| ORI | 2025/01/24 | ORI-616 Delegation of Authority This guidance describes the process for documenting the delegation of responsibilities for individuals involved in the coordination of human subject research in which key responsibilities are delegated by the Principal Investigator (PI). |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Responsibility, Delegate, PI, Oversight, Delegate | ORI-616 Delegation of Authority [PDF] |
| ORI | 2025/01/24 | ORI-616 TEMPLATE – Delegation of Authority Log Template This is a supplemental log to the Delegation of Authority Guidelines that can be modified and utilized to document tasks delegated by the PI to study personnel. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Responsibility, Delegate, PI, Oversight, Delegate, Template, Log | ORI-616 TEMPLATE – Delegation of Authority Log Template [DOC] |
| ORI | 2025/01/24 | ORI-617 Completion of Form FDA 1572 This guidance describes the process for completing and maintaining the Statement of Investigator Form (Form FDA 1572) for clinical investigators and their personnel involved in FDA-regulated clinical research studies related to the conduct of a clinical investigation of an investigational drug or biologic per 21 CFR 312. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, FDA, IND, Agreement, Application, Investigator, PI, Sponsor | ORI-617 Completion of Form FDA 1572 [PDF] |
| ORI | 2025/01/24 | ORI-618 Recruitment of Research Participants These guidelines describe the process for identifying and recruiting prospective study participants while fulfilling ethical responsibilities for protecting the rights, safety and welfare of participants. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Advertisement | ORI-618 Recruitment of Research Participants [PDF] |
| ORI | 2025/01/24 | ORI-619 Approval of Participants for Study Participation This guideline describes the process for approval of participants for study participation, regarding inclusion/exclusion criteria and documenting their eligibility. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Eligibility, Inclusion, Exclusion | ORI-619 Approval of Participants for Study Participation [PDF] |
| ORI | 2025/01/24 | ORI-619 TEMPLATE – Eligibility Checklist Template This is a supplemental template to the Approval of Participants for Study Participation Guidelines. This document can be modified to fit the eligibility criteria of a protocol and used to document eligibility review and confirmation. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Eligibility, Inclusion, Exclusion, Template, Checklist | ORI-619 TEMPLATE – Eligibility Checklist Template [DOC] |
| ORI | 2025/01/24 | ORI-619 TEMPLATE – Screening and Enrollment Log Template This is a supplemental template to the Approval of Participants for Study Participation Guidelines. This document can be used to document participant screening efforts and enrollment status. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Eligibility, Inclusion, Exclusion, Template, Log | ORI-619 TEMPLATE – Screening and Enrollment Log Template [DOC] |
| ORI | 2025/01/24 | ORI-620 Guidelines for Study Closeout This guidance describes the process and requirements for closeout of a study to ensure that all study closeout activities are conducted in compliance with regulatory requirements, organizational procedures, and sponsor policies. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Closure, End, Termination, Archive, Completion, Complete | ORI-620 Guidelines for Study Closeout [PDF] |
| ORI | 2025/01/24 | ORI-620 CHECKLIST – Study Closeout Checklist This is a supplemental checklist to the Guidelines for Study Closeout that can be used to aid in closure activities. |
HRPP, IRB, Clinical Trials, Good Clinical Practice, GCP, Closure, End, Termination, Archive, Completion, Complete, Checklist | ORI-620 CHECKLIST – Study Closeout Checklist [DOC] |