CRF-C support for Clinical Investigators

CRF-C support for Clinical Investigators

The CRF-C is equipped to support Academic/Clinical Investigators by providing the infrastructure, facilities and experienced research and specialist support staff to successfully conduct world-class patient-focused research in a safe and regulated environment to international standards. The CRF-C staff a have a wealth of experience in patient focused clinical research and also in supporting applications to a variety of funding award schemes. They can provide advice on and assistance with:

  • Clinical Trial Design and Methodology
  • Statistics
  • Clinical Trial Project Management
  • Quality and Regulatory Affairs
  • Audit and Monitoring
  • Pharmacovigilance
  • Data Management
  • Clinical Research Nurse Support‌

For further details see below:

Clinical Trial Design And Methodology

The Clinical Research Facility at UCC provides an advisory and consultation service for Academic/Clinical Investigators who wish to apply for research funding and/or carry out patient focused research.

The CRF-C can provide guidance on questions relating to study design and conduct. The CRF-C is dedicated to the promotion of clinical trials as a method of evaluation of preventive and therapeutic approaches to health problems. The goal of this consulting service is to provide intellectual and methodological input into clinical research studies being developed by clinical investigators affiliated with UCC.

Areas covered by the CRF-C clinical trial design and methodology consulting service include:

  • Help in identifying appropriate study design, which is not restricted to clinical (randomized) trials
  • Input into protocol development, including eligibility criteria, definition of interventions, randomization, outcome measurement, stopping rules, etc

 Please contact Damian O’Driscoll (Academic Research Coordinator)

Methodological and Biostatistical Support

The CRFC welcomes questions on study design, data analysis, and statistical methods from the patient-focused research community in and around Cork (researchers outside of Cork are welcome to contact the HRB-TMRN).

Please email your query to Darren Dahly PHD, Senior Lecturer in Research Methods (ddahly@ucc.ie). In the subject line, please write “CRFC Methods Query”. The body of your email should include a summary of your research project, and include your research question, what stage the project is at, and the current sources of funding. This summary of your project should then be followed by your specific question(s).

If you follow this format, you can expect a response within three days. The response will include a code (e.g. CRFC.1024) which we will ask you to include in the subject line of any subsequent correspondence.

If we are not able to address your questions in this manner, we will be happy to discuss more formal arrangements for methodological support.

We kindly ask that any assistance provided by the CRFC, should it be useful, is appropriately acknowledged in any subsequent publications, grant applications, or other output

The Clinical Research Facility Cork can provide Clinical Trials Project Management expertise to ensure that Investigator led patient focused research projects are successfully concluded on time and budget.  

These projects can range from an entire clinical trial through to a component, or sub-project, of a trial, e.g. the identification and set-up of specific investigational sites. The CRF-C Project Managers have the necessary expertise to effectively manage the project (e.g. plan, track, manage and change a project) to ensure the ultimate delivery of quality patient focused research.

Services include:

  • Project Initiation (post funding project set-up)
  • Project planning (e.g. project plan, project scope, WBS, time management, budgeting, quality plan, risk management, etc.)
  • Manage project execution (e.g. study start up, acquire & manage project team, etc.)
  • Monitoring & Controlling projects (e.g. Track the project, quality control, risk management, opportunity and change management, etc)
  • Project close out 

Please contact: Damian O’Driscoll (Academic Research Coordinator)

The CRF-C Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the CRF-C is conducted to the highest standards. The Quality and Regulatory Department currently consists of the Quality and Regulatory Affairs Manager, a Pharmacovigilance Officer, a Monitor and a Quality Executive Assistant.

Our staff are available to assist Investigators and study staff by:

Quality

  • Monitoring:  A dedicated, trained Monitor is available to carry out a full range of monitoring activities including site initiation, ongoing clinical activity monitoring, drug accountability and site close out for Health Products Regulatory Authority (HPRA) regulated and non-regulated trials.
  • GCP Training: ICH-Good Clinical Practice (GCP) training is provided for Investigators and study site personnel
  • Other Training: Other training services are avaialable to both the Principal Investigators and study site personnel as requested: e.g. Pharmacovigilance, Study Documentation etc.
  • Audits / Quality Reviews: Sponsors and Investigators can request uality reviews and audits of studies to ensure compliance with national and international legislation and guidelines.
  • Pre Study Audit: Review of study documentation (Investigator Site file) before site initiation.

Regulatory Affairs

  • Study Planning: Providing advice on prospective studies /trials to PI and study site personnel at study set up.
  • Regulatory Planning: Interacting with HPRA to seek advice on behalf of PI re prospective study/ trial.
  • HPRA Approval: Submitting Clinical Trial Applications to HPRA on behalf of PI.
  • Ethics Committee Approval: Submitting Application to Research Ethics Committees  (REC) on behalf of PI for Clinical Trials and studies.
  • Amendments: Submitting study/ trial amendments to HPRA and REC.

Please contact: Dr Ruben Keane : Quality and Regulatory Affairs Manager

The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the CRF is conducted to the highest standards.  The Quality and Regulatory Department currently consists of the Quality and Regulatory Affairs Manager, a Pharmacovigilance Officer, aMonitor and a Quality Executive Assistant.

Our staff are available to assist Investigators and study staff by:

Quality

  • Monitoring:  A dedicated, trained Monitor is available to carry out a full range of monitoring activities including site initiation, ongoing clinical activity monitoring, drug accountability and site close out for Health Products Regulatory Authority (HPRA) regulated and non-regulated trials.
  • GCP Training: ICH-Good Clinical Practice (GCP) training is provided for Investigators and study site personnel
  • Other Training: Other training services are avaialable to both the Principal Investigators and study site personnel as requested: e.g. Pharmacovigilance, Study Documentation etc.
  • Audits / Quality Reviews: Sponsors and Investigators can request uality reviews and audits of studies to ensure compliance with national and international legislation and guidelines.
  • Pre Study Audit: Review of study documentation (Investigator Site file) before site initiation.

 Please contact: Dr Ruben Keane : Quality and Regulatory Affairs Manager

Pharmacovigilance/ SAE processing for UCC sponsored studies.

The Quality and Regulatory Affairs Department carries out Serious Adverse Event (SAE) processing and pharmacovigilance activities for regulated clinical trials that are sponsored by University College Cork (UCC).

Services include:

  • Provision of a dedicated pharmacovigilance email, phone and fax for PIs to submit
  • Logging and filing of all SAEs for the study
  • SAE assessment by UCC Clinical Research Reporting Officer (CRRO (Sponsor Representative)).
  • Submission of Suspected Unexpected Serious Adverse Reactions (SUSARs) to HPRA and REC within regulatory timelines. 
  • Assisting PI with Development Safety Update Report (DSUR) preparation and submission to HPRA and REC.
  • Ongoing risk/ benefit monitoring– in conjunction with the PI. 

Please contact: Dr Ruben Keane : Quality and Regulatory Affairs Manager

Data Management services include

Study Setup

  • CRF design and development
  • Database build and testing
  • Edit Checks preparation and testing

Study Conduct

  • Data Entry
  • Discrepancy Management
  • Data review (Ongoing QC/QA)
  • Query Reconciliation (Ongoing)
  • Data Transfer

Study Closeout

  • Query Reconciliation
  • Quality Control
  • Database Lock
  • Electronic Archival
  • Database Transfer

Please contact Dr Evelyn Flannagan, Data Manager 

Clinical Services at the CRF-C

Clinical Research Nurses

CRF-C research nurses provide high quality nursing services across a broad range of therapeutic areas. The nurses provide dedicated research support for the delivery and conduct of studies whilst providing nursing care in the management of research participants.

The nurses collaborate and liaise effectively with Principal Investigators, Sponsors, affiliated research staff and external vendors in ensuring that protocol procedures are implemented with meticulous attention to ICH GCP, CRF-C SOPS and CRF-C working procedures.

The research nurses have a central role in:

  • Feasibility studies
  • Protocol implementation
  • Study conduct and coordination
  • Investigator site file management
  • Assuring participant safety
  • Patient recruitment and retention
  • Randomisation procedures
  • Data collection and entry into CRF
  • Follow up procedures
  • IMP management

Clinical Research Assistants (CRA)

Our team of Clinical Research Assistants (CRA) work under the supervision of the Research Nurses and Principal Investigators. They are a flexible delivery team who are able to assist with data collection and data management, as well as providing clinical and recruitment support.

 

Clinical Trials Physician

The CRF-C also employs a dedicated Clinical Trials physician. They play an important role in obtaining patient informed consent in a timely manner and thus ensuring efficient patient recruitment processes. They are also play an important role in carrying out AE/SAE review and carrying out routine study procedures.

Who to contact?

For Clinical Services enquires please contact Maeve Kelsey, Clinical Research Nurse Manager 

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