Information for Investigators

CRC Application Policy

Supports available

The CRC has a significant track record of supporting both investigator and industry-initiated clinical research projects. The supports include:

  • State-of-the-art facilities within major acute hospitals for high quality clinical research
  • An environment which is:
    • Supportive to clinicians to undertake hypothesis-driven investigator-led clinical studies
    • Recognised by regulators, pharmaceutical companies and clinical research organisations as being professional, of the highest quality and suitable for the conduct of clinical trials
    • Attractive to patients and encourages participation in clinical research and trials by providing excellent clinical care and access to latest clinical interventions
    • Managed under a dedicated and approved quality policy
  • A cohort of professional and experienced Research Scientists, Data Managers and Clinical Research Nurses that can ensure studies are conducted and managed to the highest levels of quality
  • Complete study management, oversight and sponsorship

 

Supports available per Study Phase

Proposal Phase

Pre-initiation Phase

Study Contact Phase

Reporting Phase

Grant Application

HPRA & Ethics submission

First Patient In

Last Patient Last Visit

Budget Review

Investigator Site File

ISF Maintenance

Study Close-out Visit

UCD Sponsorship

GCP Compliance & Training

Study Monitoring

End of Trial Notification

 

EudraCT Number

Trial Registration

Amendments

Archiving

Study Design Review

Monitoring Plan

Data Collection & Cleaning

Data Lock & Cleaning

 

Statistical Planning

Randomisation and Blinding Procedures

Pharmacovigilance

Data Transfer

Protocol Finalisation

Site Initiation

DSMB / Interim Analysis

Statistical Analysis

PIL & Consent Form

 

DSUR Submission

Budget Close Review

Insurance

 

Audits / Inspections

Clinical Study Report Submission

 

Contracts

 

 

 

 

Requesting Support

All investigators requesting access to and support from the CRC are required to complete an Application Form for review, which will be reviewed by the CRC Management Committee.

If you have any queries or need assistance on completing the application form, please email helen.campion@ucd.ie

In addition to the completed Application Form, Investigators requesting support are also asked to submit;

  • Copy of Ethics Approval for the study (or a letter stating that approval is currently being sought)
  • Copy of full Study Protocol
  • Copy of HPRA Approval (if required)