№ lp_1_2_63193
File format: docx
Character count: 6594
File size: 62 KB
The document outlines procedures for communication between research staff and sponsors/CROs throughout the course of a clinical research study.
Note:
Year
Theme:
Clinical research, communication with sponsor/CRO
Document Type:
Standard Operating Procedure (SOP)
Organization / Institution:
[INSTITUTION]
Target Audience:
Clinical research personnel, sponsor, CRO
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2015
Region / city:
Canberra
Subject:
Mental Health, Forensic Mental Health, Conditional Release
Document type:
Procedure
Organization / institution:
Canberra Health Services
Author:
Canberra Health Services
Target audience:
CHS staff, especially Mental Health, Justice Health, and Alcohol and Drug Services (MHJHADS) staff
Period of validity:
Ongoing
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2023
Region / City:
N/A
Topic:
Clinical Trials, Sponsor and CRO Engagement
Document Type:
Agenda
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Sponsor and CRO teams
Period of Effect:
N/A
Approval Date:
N/A
Revision Date:
N/A
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
Note:
Year
Subject:
Clinical trials, pharmaceutical studies
Document Type:
Agreement
Year:
20
Region / City:
Minnesota
Topic:
Clinical Trials, Research Agreements
Document Type:
Agreement
Organization / Institution:
University of Minnesota
Author:
Not specified
Target Audience:
Sponsors, Contract Research Organizations (CROs), Universities, Clinical Researchers
Duration:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2026
Region / City:
Barcelona, Spain
Type of Document:
Legal Agreement / Contract
Institution:
Hospital Universitari Vall d’Hebron; Fundació Hospital Universitari Vall d’Hebron - Institut de Recerca
Author / Signatories:
Dr. Albert Salazar i Soler, Dr. Begoña Benito Villabriga, Sponsor representative, CRO representative
Protocol Code:
[•]
EudraCT / EU CT Number:
[•]
Scope:
Clinical trial with medicinal products
Applicable Law:
Spanish national law, EU regulations, GDPR, RD 1090/2015, Regulation (EU) 536/2014, Law 41/2002
Target Audience:
Principal Investigator and research team
Effective Date:
Upon approval by regulatory authority and Ethics Committee
Responsibilities:
Sponsor, CRO, HUVH, VHIR, Principal Investigator
Confidentiality:
Required for all parties regarding trial data and personal data
Note:
Year
Topic:
Clinical Trial Agreement
Document Type:
Contract
Institution / Organization:
Istituto clinico Humanitas
Target Audience:
Medical, Scientific, and Research Professionals
Year:
2024
Region / City:
European Union
Subject:
EudraVigilance Registration
Document Type:
Registration Form
Authoring Organisation:
European Medicines Agency (EMA)
Target Audience:
Sponsors of clinical trials
Effective Period:
Not specified
Approval Date:
10 December 2024
Modification Date:
Not specified
Study name:
Abbreviated Title
IND number:
XXXXXX
Regulatory framework:
21 CFR Part 312
Jurisdiction:
United States
Document type:
Sponsor obligation transfer agreement
Transferor:
XYZ Co.
Transferee:
UTSW Medical Center
Involved authorities:
Food and Drug Administration; Drug Enforcement Administration
Scope:
Allocation of sponsor responsibilities for an Investigational New Drug
Signatories:
Current IND Sponsor; New Sponsor
Year:
2024
Region / City:
United States
Theme:
Immigration, Sponsorship
Document Type:
Form
Institution:
U.S. Citizenship and Immigration Services (USCIS)
Author:
U.S. Government
Target Audience:
Immigrants, Sponsors
Effective Period:
Expires 01/31/2026
Approval Date:
01/23/2024
Amendment Date:
N/A
Note:
Contextual description
Year:
2023
Region / City:
Rockville, Maryland
Topic:
Training Activities, Suicide Prevention, Mental Health
Document Type:
Public Report
Organization / Institution:
SAMHSA (Substance Abuse and Mental Health Services Administration)
Author:
SAMHSA
Target Audience:
Training Participants, Mental Health Professionals
Period of Action:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Contextual Description
Year:
2026
Region / City:
Gyeonggi Province, South Korea
Subject:
Internship program
Document Type:
Proposal
Institution:
Gyeonggido Job Foundation
Author:
Gyeonggido Job Foundation
Target Audience:
Sponsoring organizations
Validity Period:
2026
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Region / city:
United States
Subject:
Immigration, Affidavit of Support
Document type:
Form Instructions
Agency / institution:
U.S. Citizenship and Immigration Services (USCIS)
Author:
U.S. Department of Homeland Security
Target audience:
Sponsors and household members of intending immigrants
Effective period:
Until 01/31/2026
Approval date:
01/23/2024
Amendment date:
08/07/2024
Year:
2023
Region / City:
N/A
Topic:
Clinical Trials, Sponsor and CRO Engagement
Document Type:
Agenda
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Sponsor and CRO teams
Period of Effect:
N/A
Approval Date:
N/A
Revision Date:
N/A
Year:
2017
Region / City:
Birmingham
Topic:
Clinical Research Oversight
Document Type:
Standard Operating Procedure
Organization / Institution:
University of Birmingham
Author:
Not specified
Target Audience:
Clinical researchers, investigators, institutional oversight committees
Period of Validity:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / city:
N/A
Topic:
Clinical Trial Consent
Document Type:
Research Protocol
Organization / Institution:
DF/HCC
Author:
N/A
Target Audience:
Parents or Guardians of Children Participating in Clinical Trials
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2023
Region / City:
Raleigh, NC
Theme:
Charitable Solicitation
Document Type:
Application Form
Organization / Institution:
North Carolina Department of the Secretary of State
Author:
North Carolina Department of the Secretary of State
Target Audience:
Charitable Organizations and Sponsors
Effective Period:
N/A
Approval Date:
N/A
Date of Changes:
September 28, 2023
Year:
2022
Region / City:
Brookings
Topic:
Sponsorship, Hockey Event
Document Type:
Sponsorship Form
Organization / Institution:
Brookings Inn Convention Center
Author:
N/A
Target Audience:
Local community, hockey fans, potential sponsors
Event Date:
October 13, 2022
Registration Deadline:
October 6, 2022
Note:
Year
Year:
2025
Region / City:
N/A
Theme:
Sponsorship for ICAEW membership
Document Type:
Form
Organization:
ICAEW
Author:
ICAEW
Target Audience:
Sponsors for ICAEW Pathways applicants
Period of validity:
N/A
Date of approval:
N/A
Date of changes:
August 2025