№ files_lp_4_process_3_093291
File format: docx
Character count: 5843
File size: 52 KB
Instructional guidance and structured template for clinical research sites describing procedures and responsibilities for creating and maintaining a Clinical Quality Management Plan aligned with DMID policy and Good Clinical Practice requirements throughout the lifecycle of a clinical study protocol.
Organization:
Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID)
Country:
United States
Document Type:
Instructional template and procedural guidance
Subject Area:
Clinical research quality management
Related Standards:
Good Clinical Practice (ICH E6(R2))
Associated Systems:
DMID CROMS (Clinical Research Operations and Management Support), NIAID Clinical Research Management System (N-CRMS)
Intended Users:
Clinical research sites conducting DMID-funded clinical studies or trials
Key Roles Mentioned:
Principal Investigator, DMID Clinical Project Manager (CPM)
Scope:
Development, implementation, and oversight of site Clinical Quality Management Plans
Lifecycle Coverage:
Protocol lifecycle from implementation to data review and documentation
Referenced Authorities:
U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH)
Required Actions:
Version control, documentation review, quality control and quality assurance activities, signatures and filing of CQMP documents
Primary Components:
Protocol and site identification, quality control activities, quality assurance activities, roles and responsibilities, record selection, internal and external data sources
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Document Type:
Template
Target Audience:
Research professionals, clinical trial personnel
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
Organization:
Division of Microbiology and Infectious Diseases (DMID)
Country:
United States
Subject:
Clinical trial protocol registration requirements
Document Type:
Regulatory and procedural guidelines
Regulatory Framework:
Food and Drug Administration Amendments Act of 2007 (FDAAA); Final Rule; NIH Policy
Registry:
ClinicalTrials.gov
Scope:
Interventional Phase I–IV studies; U.S. FDA-regulated device studies; Pediatric Post-Market Surveillance; DMID-held IND/IDE; DMID-funded studies
Responsible Party:
DMID or IND holder, Principal Investigator, or designated entity under FDAAA
Registration Deadline:
Within 21 days of first subject enrollment
Oversight Roles:
Clinical Project Manager (CPM); SIO
Compliance Activities:
Quality assurance review; data query resolution; periodic protocol review
Division:
Division of Microbiology and Infectious Diseases (DMID)
Study Type:
Non-IND study
Document Type:
Investigator Agreement Form
Purpose:
Protocol Registration Package requirement
Submitting Organization:
Clinical Trials Management Contractor, Technical Resources International, Inc. (TRI)
Investigator Role:
Investigator of Record (IoR)
Required Attachments:
Curriculum Vitae or Statement of Qualifications
Regulatory Framework:
45 CFR Part 46; ICH/GCP
Oversight Bodies:
Institutional Review Board (IRB) or Ethics Committee (EC)
Obligations:
Protocol compliance; informed consent; adverse event reporting; record maintenance; IRB/EC reporting
Signature Requirement:
Investigator of Record signature and date
Year:
2021
Region / city:
United States
Topic:
Pharmacovigilance, Serious Adverse Event Reporting
Document Type:
Reporting Guidelines
Organization / Institution:
DMID-CROMS
Author:
DMID-CROMS Pharmacovigilance Group
Target Audience:
Researchers, Healthcare Professionals, Clinical Trial Investigators
Validity Period:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / city:
US
Subject:
Serious Adverse Event Reporting
Document Type:
Report
Organization:
DMID-CROMS Pharmacovigilance Group (PVG)
Author:
DMID-CROMS
Target audience:
Researchers, healthcare professionals, investigators
Effective period:
Ongoing
Approval date:
Not specified
Amendment date:
Not specified
Organization:
Division of Microbiology and Infectious Diseases
Abbreviation:
DMID
Related organization:
National Institute of Allergy and Infectious Diseases
Regulatory framework:
Good Clinical Practice
Subject area:
Clinical trial compliance and protocol deviation reporting
Document type:
Clinical research procedural guidance
Scope:
Identification, documentation, and reporting of protocol deviations in clinical studies
Responsible parties:
Principal Investigator and study site staff
Reporting timeframe:
Within 5 working days of identification or scheduled protocol activity
Applicable systems:
EMMES Internet Data Entry System (IDES / AdvantageEDC)
Oversight bodies:
Institutional Review Board / Independent Ethics Committee
Data management organization:
The Emmes Company, LLC
Submission platforms:
DMID-CROMS website, fax, or e-mail submission system
Documentation requirement:
Completion and maintenance of a DMID Protocol Deviation Form in site regulatory files and subject source documents
Note:
Year
Topic:
Educational Strategies, Mathematics
Document Type:
Instructional Guide
Target Audience:
Educators, Teachers
Note:
Year
Note:
Year
Topic:
Mathematics
Document Type:
Instructional Guide
Organization / Institution:
Florida Department of Education
Target Audience:
Educators
Year:
2021
Region / city:
Florida
Theme:
Mathematics Education
Document Type:
Instructional Guide
Organization / Institution:
Florida Department of Education
Author:
Florida Department of Education
Target Audience:
Educators, Teachers
Period of Validity:
Ongoing
Approval Date:
Not specified
Date of Changes:
Ongoing updates
Document type:
Instructional protocol
Assessment framework:
DIBELS
Educational context:
Literacy instruction
Intended users:
Teachers and instructional leaders
Professional setting:
Professional learning communities (PLC)
Education levels:
Pre-K through Grade 4+
Instructional focus:
Reading development and phonological skills
Process structure:
Eight-step data analysis cycle
Example data source:
Nonsense Word Fluency (NWF)
Referenced organization:
Springboard Collaborative
Components included:
Protocol steps, think-aloud example, teacher planning sheet
Note:
Year
Year:
2024
Region / City:
United States
Subject:
Safety Assurance Evaluation
Document Type:
Instructional Reference
Organization:
FAA
Author:
Daniel J. Elgas
Target Audience:
Approval holders in the aviation industry
Period of Validity:
Ongoing
Approval Date:
05/03/2024
Amendment Date:
N/A
Year:
2022
Region / City:
New South Wales, Australia
Curriculum:
English K–10 Syllabus
Stage:
Stage 2
Years:
3–4
Type of document:
Instructional sequence / curriculum guide
Institution:
NSW Education Standards Authority (NESA)
Target audience:
Teachers and educators
Content focus:
Phonology, orthography, morphology
Structure:
Term-based with weekly instructional blocks
References:
Garcia et al. 2010; Daffern 2017; Devonshire and Fluck 2010; Madelaine 2023; Westwood 2023; NESA 2022
Symbols:
*, #, ^
Instructional hours:
90–100 minutes per week recommended
Note:
Provides guidance on sequencing, content repetition, and integration with vocabulary, reading comprehension, and literature study.
Year:
Not specified
Region / City:
Massachusetts
Theme:
Curriculum development, instructional materials selection
Document Type:
Guide
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
District leaders, teachers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Texas
Topic:
Geometry, Statistics, Education
Document Type:
Instructional Guide
Organization / Institution:
Texas Education Agency
Author:
Not specified
Target Audience:
Educators, Pre-AP teachers
Period of validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
{Insert Date}
Note:
Region / City
Theme:
Configuration Management
Document Type:
Instructional Guide
Organization / Institution:
NASA
Target Audience:
Spacecraft developers outside of NASA
Effective Date:
{Insert Date}
Note:
Year
Subject:
Biology
Document Type:
Instructional Planning Guide
Target Audience:
Educators, Pre-AP Biology Teachers