№ lp_1_26868
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File size: 346 KB
This document is a template designed for creating clinical trial protocols for Phase 2 and 3 trials funded by NIH and regulated by FDA under IND or IDE applications.
Note:
Year
Subject:
Clinical Trials, FDA, NIH, IND, IDE
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH)
Target Audience:
Clinical Researchers, Investigators
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2023
Region / City:
United States
Subject:
Clinical Trial Protocol
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH)
Author:
NIH Clinical Trials Division
Target Audience:
Clinical trial investigators, healthcare professionals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Year:
2009-10
Region / City:
Not specified
Theme:
College Management System, Grid Framework
Document Type:
Project Report
Institution:
Not specified
Author:
Ruchira Bhagat, Pooja Kadam, Priyanka Mali, Monica Landge
Target Audience:
Not specified
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
Not specified
Region / city:
Not specified
Theme:
Construction Contract
Document Type:
Contract
Agency / organization:
Board of Regents of the University System of Georgia
Author:
Not specified
Target audience:
Contractors, Owners, and related parties in construction projects
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
1948
Region / City:
Finca-Vidalia, San Francisco de Paula, Cuba
Topic:
War, Literature, Personal Experience
Document Type:
Preface
Author:
Ernest Hemingway
Target Audience:
General public, readers of Ernest Hemingway
Period of Action:
1929, 1948
Date of Approval:
1948
Date of Changes:
1948
Year:
2021
Region / City:
National Institutes of Health (NIH), USA
Topic:
Behavioral and Social Clinical Trials
Document Type:
Protocol Template
Organization / Institution:
National Institutes of Health (NIH)
Author:
National Institutes of Health (NIH)
Target Audience:
Clinical investigators, researchers
Effective Period:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
1993
Region / City:
Stanford, California
Theme:
Bilingual education, federal education policy
Document Type:
Report
Author:
Working Group on Federal Education Policy
Target Audience:
Policymakers, educational researchers, educators, and advocates
Period of Validity:
Ongoing
Approval Date:
May 27, 1993
Date of Last Revision:
May 27, 1993
Note:
Context
Year:
2021
Region / Country:
New Zealand
Topic:
Māori involvement in the state care system and historical abuse in care
Document type:
Research report (title pages, preface, and executive summary)
Commissioning body:
Crown Response to the Abuse in Care Inquiry
Research organization:
Ihi Research
Authors:
Catherine Savage; Paora Crawford Moyle; Larissa Kus-Harbord; Annabel Ahuriri-Driscoll; Anne Hynds; Kirimatao Paipa; George Leonard; Joanne Maraki; John Leonard
Contributors:
Wendy Dallas-Katoa; Hēmi Te Hēmi; Elaine Donovan; Kate Standring; Letitia Goldsmith; Annie Guerin
Publication date:
July 2021
Period covered:
1950–1999
Related inquiry:
Royal Commission of Inquiry into Historical Abuse in State Care and in the Care of Faith-based Institutions
Approach:
Kaupapa Māori / Māori-centred research approach
ISBN:
978-1-99-115376-0
Publisher:
Ihi Research
Copyright:
© 2021 Ihi Research
Design and print:
Create Design Studio
Photo credit:
Graeme Johnston
Art credit:
Paora Crawford-Moyle
Year:
2021
Region / city:
Global
Topic:
Cybersecurity, Malware Analysis
Document Type:
Guide
Organization / Institution:
Independent
Author:
Unknown
Target Audience:
Cybersecurity enthusiasts, professionals, and analysts
Period of Validity:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2026
Region / City:
Not specified
Topic:
Terminology, Love, Christianity, Human Relations
Document Type:
Preface
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
General public, scholars of theology and philosophy
Period of validity:
Indefinite
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Year:
Unknown
Region / City:
Qumran / Ethiopia
Subject:
Religious Texts / Prophecy
Document Type:
Restored Scroll
Institution:
Not specified
Author:
Chanokh (Enoch)
Intended Audience:
Elect and righteous
Original Languages:
Aramaic, Hebrew, Ethiopic
Restoration Languages:
English, Hebrew transliteration
Period Covered:
From Adam to the last days
Date of Restoration:
Not specified
Source Manuscripts:
Dead Sea Scrolls (4QEnoch), Ethiopic manuscripts (Ge’ez), Greek fragments (Akhmim, Syncellus)
Structure:
Six core scroll-books with chapters I–VI
Divine Names Restored:
Yahuah, Yahusha
Year:
2024
Region / City:
Pretoria
Subject:
Court Schedules
Document Type:
Court Listing
Institution:
Gauteng Division, Pretoria
Target Audience:
Legal professionals, Court staff
Period of Validity:
20 February 2024
Approval Date:
20 February 2024
Date of Changes:
N/A
Jurisdiction:
Australia
Regulatory framework:
Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme
Document type:
Regulatory notification form
Scope:
Clinical trials involving medicines, biologicals, medical and therapeutic devices
Trial phases covered:
Phase I–IV, bioavailability/bioequivalence, device studies
Subjects:
Human participants
Ethics oversight:
Human Research Ethics Committee (HREC)
Approving authority:
Relevant institutional authority
Geographic coverage:
Australian trial sites with optional international sites
Responsible party:
Lead Investigator
Fee responsibility:
Lead Investigator
Related institution:
La Trobe University
Submission requirement:
Completed form and ethics approval
Note:
Year
Subject:
Clinical Trials, Medical Research
Document Type:
Template
Organization / Institution:
EU Clinical Trials Expert Group
Target Audience:
Sponsors of clinical trials
Document type:
Instructional guidance
Subject:
Informed consent forms in clinical research
Context:
Clinical trials involving human participants
Regulatory and ethical framework:
Research ethics and regulatory compliance
Organizations referenced:
Children’s Oncology Group; National Cancer Institute; National Institutes of Health; OCREB
Funding context:
Public funding by the National Cancer Institute
Intended audience:
Consent form authors; clinical trial investigators; participating centres
Geographic scope:
North America
Population referenced:
Children and adolescents with cancer; parents or legal guardians
Related materials:
Provincial informed consent form templates; lay terminology glossary
Year:
2025
Region / city:
Ireland
Topic:
Clinical trials, Primary care, Research funding
Document type:
Request Form
Organization / institution:
Health Research Board
Author:
HRB Primary Care Clinical Trials Network
Target audience:
Lead Investigators in clinical trials
Effective period:
Until November 2026
Approval date:
N/A
Date of amendments:
N/A
Year:
2024
Region / City:
N/A
Topic:
Critical Appraisal
Document Type:
Checklist
Organization / Institution:
Critical Appraisal Skills Programme (CASP)
Author:
Critical Appraisal Skills Programme (CASP)
Target Audience:
Healthcare professionals, researchers
Date of Approval:
N/A
Date of Modification:
N/A
Note:
Year
Document type:
Template
Institution / organization:
EU Clinical Trials Expert Group
Target audience:
Sponsors of clinical trials
Year:
2023
Region / City:
Rwanda
Theme:
Clinical Trials, Good Clinical Practice (GCP) Inspection
Document Type:
Guidelines
Organization / Institution:
Rwanda Food and Drugs Authority (Rwanda FDA)
Author:
Dr. Emile BIENVENU
Target Audience:
Clinical trial regulators, researchers, pharmaceutical professionals
Period of Validity:
Starting from 23/07/2021
Approval Date:
20/05/2021
Date of Revision:
06/01/2023