№ lp_1_31430
File format: docx
Character count: 42019
File size: 209 KB
This document is a template providing a recommended structure for developing consistent study procedure implementation and data collection instructions for clinical trials.
Year:
2023
Region / City:
Not specified
Topic:
Clinical trial procedures, data management
Document type:
Manual
Organization / Institution:
National Institute of Mental Health (NIMH)
Author:
Not specified
Target audience:
Principal Investigator, study team members
Effective period:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
N/A
Subject:
Clinical Study Procedures and Data Collection
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
Author:
N/A
Target Audience:
Principal Investigator and study team members
Effective Period:
Until study completion
Approval Date:
N/A
Modification Date:
N/A
Year:
2020
Note:
Region / City
Topic:
Clinical Research
Document Type:
Guideline
Organization / Institution:
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Target Audience:
Researchers, Clinical Trial Coordinators, Investigators
Project Name:
Penn State
Project Number:
11191
Building Name:
X - Building Engineers Assistance Required
Work Area:
Electric Room
Facility Address:
1200 Normandy Pl, Philadelphia, PA
Requested Start:
11/05/16 11pm
Requested Work Window:
11/05/16 11pm – 11/06/16 5am
Completion Date:
11/06/16
Client:
Penn State
Contractor:
[Contractor Name]
Safety Measures:
LOTO, Arc Flash Suit, Temporary Generator
Impact:
Power shutdown approximately 6 hours affecting lighting and alarms
Document Type:
Method of Procedure (MOP)
Authorizations:
Contractor Project Manager, Owner Project Manager, Contractor Electrical Services
Subcontractor & Vendor Contacts:
Listed
Supporting Documentation:
Floor Plans, Flow Diagram, Three Line Diagram, Wiring Diagrams, Arc Flash Safety Policy, Lockout/Tagout Procedures, MSDS Sheets, Facility Standard Maintenance Procedure
Year:
2020
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Document Type:
Guidelines and Template
Scope:
Single-site clinical trial procedures
Version:
v.All
Date of Issue:
December 2020
Target Audience:
Study teams and administrative support staff
Protocol Number:
[Not specified]
Study Principal Investigator:
[Not specified]
Site Name:
[Not specified]
Grant/Contract Number:
[Not specified]
Funded by:
[Not specified]
Organization:
National Center for Complementary and Integrative Health
Acronym:
NCCIH
Document type:
Guidelines
Subject area:
Clinical research operations
Scope:
Multisite and single-site clinical trials
Intended users:
Principal investigators and study staff
Related regulations:
Institutional Review Board requirements; Data and Safety Monitoring
Referenced entities:
NIH; FDA; Data and Safety Monitoring Board
Structure:
Table of contents with sections and appendices
Includes templates:
Yes
Source type:
Institutional guidance document
Year:
2026
Organization:
Tertiary Education Commission (TEC)
Document type:
Instruction / Form Submission Guide
Audience:
Education providers submitting qualification changes
Subject:
Qualification and credential amendments
Region:
New Zealand
Submission method:
Email to [email protected]
Required fields:
Fund, Qualification code, Qualification name, NZQCF level, Region of delivery, Funding rate, EFTS/hours, Comments
Context:
Instructional document for education providers detailing how to report proposed changes to qualifications and credentials, including reasons, stakeholder engagement, and funding information.
Note:
Year
Topic:
Regulatory compliance, human subject research
Document type:
Checklist
Organization / Institution:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Year:
Not specified
Region / City:
Not specified
Topic:
Adverse events tracking in clinical studies
Document Type:
Template
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Site Monitors, Principal Investigators, study team members
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Note:
Year
Target Audience:
Principal Investigators and study team members
Purpose:
This template may be used to record and track regulatory documents for human subject research clinical trials with Investigational Product (IP) not under an FDA IND/IDE
Study-related documents:
IRB approval documents, DSMB correspondence, NIMH grant-related documents, Study Staff training, Investigational Product documentation
Context:
A regulatory checklist for managing essential documents required in human subject research clinical trials with an investigational product not under an FDA IND/IDE.
Note:
Year
Subject:
Concomitant medications tracking
Document Type:
Template
Organization / Institution:
NIMH
Target Audience:
Principal Investigators, study team members
Year:
2023
Region / city:
United States
Topic:
Clinical research, FDA IND/IDE, Regulatory compliance
Document type:
Checklist
Organization / institution:
National Institute of Mental Health (NIMH)
Author:
National Institute of Mental Health (NIMH)
Target audience:
Principal Investigators, study team members
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
United States
Topic:
Clinical trials, Regulatory documentation
Document type:
Checklist
Organization / Institution:
NIMH
Author:
NIMH
Target Audience:
Principal Investigators, study team members
Period of validity:
Ongoing
Approval Date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
N/A
Topic:
Delegation of authority, Research study management
Document Type:
Template
Organization / Institution:
National Institute of Mental Health (NIMH)
Author:
N/A
Target Audience:
Principal Investigators, Study team members
Period of validity:
N/A
Approval Date:
N/A
Date of amendments:
N/A
Note:
Year
Subject:
Investigational Product Management
Document Type:
Standard Operating Procedure
Institution:
National Institutes of Health
Target Audience:
Principal Investigator, Study Team Members
Note:
Year
Target Audience:
Principal Investigator and study team members who are delegated to manage investigational products