Information for Investigators

CRC Access and Support

All investigators requesting access to and support from the UCD Clinical Research Centre are required to complete the application form for review by the CRC Management Group.

In addition to the completed form, investigators are also asked to submit:

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

For industry sponsored studies, defined recharge rates apply. Details are available from the CRC Business Development Manager. These rates have been standardised across all sites and studies. Please contact us for more information.

Services available to investigators

The UCD CRC has a range of facilities and in-house expertise to support the delivery of high quality clinical research to its collaborators and partners. These supports cover all aspects of the clinical research project lifecycle, from protocol development and approval, study design and management, through active recruitment and sample collection, to sample and data analysis.

We have dedicated supports for all phases of the clinical trial process:

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 Archiving
  • EudraCT Number
  • Trial Registration
  • Amendments, Data Collection and Cleaning
  • Data Lock & Cleaning
  • Study Design Review
  • Monitoring Plan
  • Pharmacovigilance
  • Data Transfer
  • Statistical Planning
  • Randomisation and Blinding Procedures
  • DSMB/Interim Analysis
  • Statistical Analysis
  • Protocol Finalisation
  • Site Initiation
  • DSUR Submission
  • Budget Close Review
  • PIL & Consent Form
 
  • Audits/Inspections
  • Clinical Study Report Submission
  • Insurance
     
  • Contracts
     

Clinical Research Facilities

  • Consulting and Procedure Rooms: The UCD CRC has a suite of clinical consulting rooms, as well as procedure and recovery rooms supporting moderately invasive procedures such as arthroscopy. Access to a research dedicated DEXA scanner is also available.
  • IMP Management: The UCD CRC can offer secure, monitored, fully auditable, refrigerated and room temperature IMP storage.
  • Database design and support: In order to support effective and secure clinical data management across all studies, the UCD CRC can offer design of study specific databases.
  • Clinical Trial Sponsorship: UCD CRC can act as a sponsor for non-commercial, investigator-initiated clinical trials.

Clinical Research Nurses

  • Clinical Role: The research nurses at the UCD CRC are a primary point of contact for the subjects and play a major role in informing patients of the study schedule and procedures and obtaining the informed consent for all clinical studies.
  • Study Management: an important responsibility of the research nurse is managing the responsibility taken on all research studies at the hospital site in collaboration with the investigators and being accountable for individual activities.
  • Quality Control and Review: active participation in study audits and quality checks, whether held internally or externally.

Quality & Regulatory Affairs

  • Protocol Development: The UCD CRC has significant experience in the development of clinical trial protocols for investigator initiated trials. The UCD CRC can also provide support for funding applications.
  • Support with Regulatory and Ethics submissions: the UCD CRC can support with the strategy for submissions and assist with the finalisation of the clinical trial dossier required to obtain the relevant regulatory and ethics approval.
  • Quality Control & Auditing: Aside from external audits, the UCD CRC has the capacity to internally audit and review the conduct of clinical trials within the facilities by all staff actively working on clinical trials.

Scientific Services

The UCD CRC provides a broad range of laboratory services, including biobanking and sample analysis at both sites. In addition, the St Vincent’s site also houses the UCD Abbott Core Biomarker Laboratory, which provides both investigators and industry with biomarker analysis services.

Additional Staffing Supports

  • Research Assistants: In order to support data entry, data management, and non-clinical study-related tasks the CRC can allocate research assistant resources as required.
  • Laboratory technicians: As part of the overall scientific services portfolio the UCD CRC employs technicians at each site which can support a wide variety of sample processing requirements.

Standard Operating Procedures | Sample Processing

Sample Processing SOPs

The SOPs in this section describe general procedures for processing of biological materials for use in subsequent molecular analysis.

SOP NumberTitleLink
5.1 DNA Extraction from Blood 5.1 
5.2 RNA Extraction from Blood 5.2 
5.3 Protein Extraction from Blood 5.3 
5.4 Processing of Urine 5.4 
5.5 Processing of Faeces 5.5 
5.6 Processing of Buccal Swabs 5.6 
5.7 Processing of Tissue 5.7 

 

 

Standard Operating Procedures | Sample Storage

Included in this section are SOPs for storing biospecimens at the CRC.

SOP NumberTitleLink
6.1 Biospecimen Transport and Labelling 6.1 
6.2 Biospecimen Storage 6.2 
6.3 Bioresource Area Monitoring and Management 6.3