№ lp_1_2_69034
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Standard Operating Procedure (SOP) for the collection, transcription, and management of clinical research data to Case Report Forms (CRFs) for clinical trials.
Year:
2015
Region / City:
Not specified
Topic:
Clinical Trials, Data Management
Document Type:
SOP (Standard Operating Procedure)
Organization / Institution:
Clinical Research Center (CRC)
Author:
Not specified
Target Audience:
Research staff, investigators
Validity Period:
Not specified
Approval Date:
01/01/2015
Effective Date:
01/01/2015
Review / Revision Date:
01/01/2015
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2020
Region / City:
Clark County, Ohio
Topic:
Housing and Emergency Assistance Grants
Document Type:
Government Assistance Program
Organization:
Clark County Community & Economic Development
Author:
Dirk Lackovich-Van Gorp, Grants Coordinator
Target Audience:
Individuals, families, and households in Clark County, Ohio affected by COVID-19
Period of Validity:
March 1, 2020 – December 31, 2020
Approval Date:
October 14, 2020
Revision Date:
November 19, 2020
Year:
2025
Event:
October CRF Forum
Location:
Ft. Lauderdale, FL, USA
Type:
Conference agenda and ROI justification
Organizer:
Credit Research Foundation
Audience:
Company executives and finance professionals
Duration:
3 days
Purpose:
Present ROI and justify attendance costs
Key Topics:
Credit risk management, process innovation, cash flow optimization, benchmarking, professional development
Attachments:
Estimated investment breakdown, post-conference report plan
Year:
2019
Region / city:
Not specified
Subject:
Clinical trial documentation, Case Report Form (CRF) design
Document type:
SOP (Standard Operating Procedure)
Organization:
ALERRT (Association for Data Management in the Tropics)
Author:
Hanne Landuyt
Target audience:
Clinical trial staff, Data managers, Investigators
Period of validity:
Not specified
Approval date:
01/02/2019
Revision date:
10/10/2019
Date of changes:
20/06/2022
Year:
2015
Region / City:
Virginia
Topic:
Foster care, child safety, employee verification
Document Type:
Safety memorandum
Institution:
Virginia Department of Social Services, Department of Behavioral Health & Developmental Services
Author:
U.S. Department of Health & Human Services, Children’s Bureau
Target Audience:
Residential facilities for foster care children, facility administrators, human resource managers
Effective Period:
Ongoing
Approval Date:
September 1, 2014
Date of Changes:
September 21, 2015
Year:
2023-2028
Region / city:
Norfolk, UK
Theme:
Equality, Diversity and Inclusion in Research
Document type:
Strategic Vision Statement
Organization / Institution:
NIHR Norfolk Clinical Research Facility
Author:
NIHR Norfolk CRF Management Team
Target audience:
Staff, patients, public research participants, healthcare professionals
Period of validity:
2023-2028
Approval date:
2023
Date of changes:
None
Program Name/Jurisdiction:
Maryland Breast and Cervical Cancer Program and/or CRF Cancer Prevention, Education, Screening and Treatment Program
Fiscal Year:
2024
Document Type:
Administrative standards and eligibility guidelines
Geographic Scope:
Maryland, United States
Administering Authority:
Local Maryland cancer screening programs
Subject:
Eligibility criteria for screening, diagnostic, referral, and treatment services
Target Population:
Maryland residents seeking cancer screening and related services
Eligibility Criteria:
Residency, annual gross household income up to 250% of Federal Poverty Level, family size, insurance status
Verification Requirements:
Verbal or written proof of residency, income documentation, insurance verification, Medicaid status confirmation via EVS
Programs Referenced:
BCCP-CPEST Programs, Patient Navigation Only (PNO), Cancer Screening and Tracking (CaST), Client Database (CDB)
Standards Referenced:
Minimal Clinical Elements (MCE), Minimal Standards for Nursing Case Management
Year:
FY26
Region / City:
NHS Organisation
Subject:
NHS Organisation – FastTrack FRP
Document Type:
Claim Registration Form
Author:
Microsoft
Target Audience:
Eligible Microsoft FastTrack Ready Partners and NHS Organisations
Period of Action:
FY26
Date of Approval:
Not specified
Date of Changes:
Not specified
Year:
Not specified
Region / City:
Not specified
Topic:
Myasthenia Gravis monitoring
Document Type:
Case Report Form
Organization / Institution:
Clinical research study
Target Audience:
Clinical investigators, study coordinators
Assessment Tools:
MGFA Post Intervention Status, MG Scale, QMG Score, MG-MMT Score, MG-ADL Score, MG-QOL15 Score
Data Classification:
Core and supplemental elements
Frequency of Completion:
Every study visit
Patient Status Categories:
CSR, PR, MM-0, MM-1, MM-2, MM-3, Improved, Unchanged, Worse, Exacerbation, Died of MG
Instructions:
Includes general and specific guidance for CRF completion
Source Type:
Clinical research form
Structured Data:
Quantitative and qualitative assessment of MG severity and progression
Data Dictionary Reference:
Definitions and classifications of CRF elements included
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
Year:
2018
Region / City:
Melbourne
Subject:
Clinical Trials, Monitoring, Investigator-Initiated Trials
Document Type:
Template
Organization / Institution:
Melbourne Children’s Trials Centre, Clinical Research Development Office (CRDO)
Author:
Not specified
Target Audience:
Sponsor-Investigators, Clinical Research Professionals
Effective Period:
Not specified
Approval Date:
01 May 2018
Date of Changes:
Not specified
Note:
Year
Subject:
Clinical Trials, FDA, NIH, IND, IDE
Document Type:
Template
Organization / Institution:
National Institutes of Health (NIH)
Target Audience:
Clinical Researchers, Investigators
Document type:
Application form
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Country:
South Africa
Subject:
Additions and/or changes in investigators and clinical trial sites
Document number:
GLF-CEM-CT-01D
Related form:
CTF3
Version:
v4
Date of first approval:
October 2019
Date of latest update:
September 2022
Update history:
October 2019 first version approved; March 2020 administrative changes; September 2022 administrative changes, checklist update, appendix removal, document number change
Applicable actions:
Additional investigator(s); Change of investigator(s); Additional site(s); Change in site location
Required attachments:
Cover letter; Investigator documents; Site staff documents; Proof of payment
Approval bodies referenced:
Ethics Committee(s)
Intended applicant:
Sponsor, CRO, or local sponsor company
Regulated area:
Clinical trials
Organization:
Joanna Briggs Institute (JBI)
Document type:
Critical appraisal tool / checklist
Topic:
Randomized controlled trials (RCTs)
Target audience:
Researchers conducting systematic reviews
Year:
2020
Source:
JBI Manual for Evidence Synthesis
Format:
Checklist for individual participants in parallel group RCTs
Purpose:
Assess methodological quality and risk of bias in RCTs
Reference:
Tufanaru C, Munn Z, Aromataris E, Campbell J, Hopp L. Chapter 3: Systematic reviews of effectiveness