№ files_lp_4_process_2_59235
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Formal agreement regulating the execution of a clinical trial with medicinal products, detailing responsibilities, compliance with Spanish and EU regulations, monitoring, audits, and data confidentiality for all parties involved.
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
Price: 8 / 10 USD
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Procedure for reporting regarding persons subject to a Conditional Release Order (CRO)
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
Kick-Off Meeting Agenda for New Sponsor and CRO Engagement
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
Explanatory note for the 20.05.24 Tripartite CRO model Clinical Trial Agreement for use in all interventional clinical trials in Ireland
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
Standard Clinical Trial Agreement with Clinical Research Organisation (“CRO”)
Note: Year
Subject: Clinical trials, pharmaceutical studies
Document Type: Agreement
ACCELERATED CLINICAL TRIAL AGREEMENT- CRO Version
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
Communication with Sponsor or Contract Research Organization (CRO)
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
Topics: HUVH VHIR CRO