№ files_lp_4_process_3_123426
File format: docx
Character count: 2903
File size: 40 KB
Clinical research site record form defining categories, codes, and recording fields for documenting protocol deviations during observational and interventional studies and for reporting them to institutional review oversight.
Document Type:
Clinical research record log
Purpose:
Recording protocol deviations occurring at a study site during clinical research studies
Field:
Clinical Research
Research Type:
Observational and Interventional Studies
Maintained In:
Study Binder (Investigator Binder, Regulatory Binder, Investigator Site File, Study File)
Responsible Personnel:
Study coordinators, principal investigators (PIs), site staff
Oversight Bodies:
Institutional Review Board (IRB), Study Sponsor Monitor
Related Procedure:
OHRE/IRB SOP 1401
Deviation Categories:
Informed Consent, Eligibility, Protocol Implementation, Reporting, Other
Deviation Codes:
Standardized numerical codes for protocol deviation classification
Record Structure:
Page-numbered log with reverse chronological storage
Reporting Requirement:
Deviations reported to the IRB according to IRB Standard Operating Procedures
Key Data Fields:
Reference Number, Subject ID, Date of Deviation, Date Identified, Deviation Description, Deviation Type, Adverse Event Indicator, Study Continuation Status, IRB Reporting Requirement, IRB Reporting Date
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2018
Region / city:
Vale of York, Scarborough and Ryedale
Theme:
Varicose Veins Management
Document type:
Commissioning Policy
Organization:
NHS Vale of York and Scarborough and Ryedale CCGs
Author:
Not specified
Target audience:
Healthcare professionals, Primary care clinicians, Vascular surgeons
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
2018
Document type:
Guidance document
Subject:
Informed consent in interventional clinical trials
Population:
Healthy adult participants
Scope:
Interventional clinical trials with trial medicine
Jurisdiction:
Belgium
Organizations mentioned:
CT College; Healixia; Ethics Committees; Belgian Data Protection Authority
Language versions:
English; French; Dutch
Intended users:
Clinical trial sponsors
Regulatory context:
Ethics Committee submission requirements
Version:
1.0
Year:
2024
Region / City:
Ireland
Topic:
Clinical Trials, Legal Agreements, Healthcare
Document Type:
Explanatory Note
Organization:
HSE, IPHA
Target Audience:
Contract Research Organizations, Hospitals, Pharmaceutical Companies
Effective Date:
20.05.24
Related Date:
20.05.24
Approval Date:
20.05.24
Year:
2021
Region / City:
Brussels
Topic:
Clinical Research Ethics
Document Type:
Submission Form
Institution:
Saint-Luc University Clinics (CUSL)
Author:
Ethics Committee
Target Audience:
Researchers, Clinical Trial Investigators
Period of Validity:
2021-2022
Approval Date:
N/A
Date of Changes:
N/A
Year:
2019
Region / City:
Toronto, Canada
Topic:
Informed consent, Clinical trial
Document Type:
Template, Informed consent form
Institution:
SickKids
Author:
SickKids REB
Target Audience:
Parents, Researchers
Effective Period:
N/A
Approval Date:
November 14, 2019
Modification Date:
N/A
Year:
2019
Region / City:
SickKids, Canada
Topic:
Clinical Trial Consent Form
Document Type:
Template
Organization:
SickKids Research Ethics Board
Author:
SickKids
Target Audience:
Research Teams, Clinical Trial Participants
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
Spring 2009
Region / City:
Dartmouth-Hitchcock Medical Center
Subject:
Interventional Radiology Procedures
Document Type:
Clinical Manual
Institution:
Dartmouth-Hitchcock Medical Center
Author:
Not specified
Target Audience:
Medical professionals in interventional radiology
Effective Period:
Ongoing for clinical rotations
Approval Date:
Spring 2009
Date of Last Revision:
Not specified
Year:
2024
Region / City:
United Kingdom
Topic:
Health Technology Evaluation
Document Type:
Meeting Minutes
Organ / Institution:
National Institute for Health and Care Excellence (NICE)
Author:
Committee members and NICE staff
Target Audience:
Healthcare professionals, policy makers, and stakeholders in health technology evaluation
Period of validity:
10 October 2024
Approval Date:
10 October 2024
Date of Changes:
None
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
Year:
2023
Region / city:
Livingstone, Zambia; Lusaka, Zambia; Twickenham, London, UK; Nashville, TN, USA
Subject:
Hypertension, dietary salt, inflammation
Document type:
Research study
Organization / institution:
Mulungushi University, University of Zambia, St. Mary’s University, Vanderbilt University Medical Center
Author:
Sepiso K. Masenga, Leta Pilic, Benson M. Hamooya, Selestine Nzala, Geoffrey Kwenda, Douglas C. Heimburger, Wilbroad Mutale, John R. Koethe, Annet Kirabo, Sody M. Munsaka
Target audience:
Researchers, healthcare professionals
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Document type:
Sponsor statement template
Subject:
Use of Belgian Model Informed Consent Form for vaccine trials in adult healthy volunteers
Related procedure:
Clinical trial application
Scope:
Interventional trials with investigational vaccines
Geographical reference:
Belgium
Applicable to:
Sponsors of clinical trials
Referenced document:
Belgian Model ICF for Vaccine Trials in Adult Healthy Volunteers
Required information:
EU number, trial number, sponsor details, adaptations to mandatory text if applicable
Signature requirement:
Sponsor representative in the Member State
Date format:
DD/MMM/YYYY
Year:
2019
Location:
Minneapolis, MN, USA
Subject:
Construction and Site Preparation for Interventional Radiology Rooms
Document Type:
Government Solicitation / Contract Offer
Issuing Agency:
Department of Veterans Affairs, Program Contracting Activity Central
Author/Contracting Officer:
Bailey E. Donato
Target Audience:
Service-Disabled Veteran-Owned Small Businesses (SDVOSB)
Contract Value:
Between $2,000,000 and $5,000,000
Performance Period:
To be specified in the contract after award
Submission Deadline:
April 16, 2019, 3:00 PM EST
Contract Method:
Sealed Bid / Negotiated RFP
Legal Reference:
38 U.S.C. § 8127 (Public Law 109-461)
Required Documentation:
Performance and payment bonds if applicable, completed offer forms, acknowledgment of amendments
Year:
2018
Region / City:
Minneapolis, MN
Subject:
Interventional Radiology Physician Services
Document Type:
Contract Award Notice
Agency:
Department of Veterans Affairs
Contracting Office:
NETWORK 23 CONTRACTING OFFICE, 316 Robert Street N., St. Paul, MN 55101
Award Number:
36C26318C0043
Award Amount:
$1,497,228.00
Award Date:
02-05-2018
Awardee Name:
MINNEAPOLIS RADIOLOGY
Awardee DUNS Number:
078882836
Awardee Address:
2955 XENIUM LN N STE 40, MINNEAPOLIS, MN 55441
Point of Contact:
[email protected]
NAICS Code:
621111
Set-Aside:
Not specified
Archive Days:
Not specified
Recovery Act Funds:
Not specified
Note:
Year
Subject:
Subcontractor Deviation Disposition Request Process
Document Type:
Instruction Manual
Organization / Institution:
Los Alamos National Laboratory (LANL)
Target Audience:
Subcontractors, Procurement, Engineering Teams
Note:
Date of event
Note:
Year
Year:
2023
Region / City:
N/A
Topic:
Request for deviation or waiver related to procurement processes
Document Type:
Form
Agency / Organization:
Sikorsky
Author:
N/A
Target Audience:
Contractors, procurement officers
Validity Period:
N/A
Approval Date:
N/A
Modification Date:
N/A
Form number:
KSU-IRB 022-E
Document type:
Log form
Topic:
Protocol deviations in human subjects research
Institution:
King Saud University
Oversight body:
Research Ethics Committee
Regulatory context:
Institutional Review Board compliance
Related roles:
Principal Investigator; Compliance Monitor; IRB
Included sections:
Protocol information; Deviation records; CAPA plan; Findings; Signatures
Applies to:
Research involving human participants
Source type:
Institutional research compliance record