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 advisory committee.

Help in completing the form is available from Ms Jackie Breiden (MMUH Campus) or Ms Mary McGrath (SVUH Campus).

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 CRC staff. These rates have been standardised across all sites and studies. Please contact us for more information.


Prior to Application

Prior to study initiation in the CRC, the study team and primary investigator meet with the CRC nursing staff who have been selected to work up the study. As part of this process, the CRC nurse will develop a set of protocols ensuring that all CRC clinical research nurses can implement the study in the same manner, ensuring data collection is consistent.

The principal investigator is responsible for reviewing and approving the flow sheets before the subject visits begin. The CRC nurse may also assist the study team in developing standards (orders) for study visits to the CRC, and will also help develop sample processing guidelines for the research samples collected during the CRC visits.

An added benefit of this process is the review of the protocol by an experienced research nurse will help resolve potential issues affecting implementation. In some cases, the study staff may be invited to participate in in-service training the CRC staff on specific aspects of a study. The success or otherwise of a study may depend on co-operation in this regard and the collaboration of study staff will be required before study can begin.

Application Process

All Investigators wishing to access the CRC facilities must complete an application form as described. This form will be reviewed by the CRC advisory committee prior to project initiation.

An overview of the CRC approval process is available here: CRC Flowchart 

Standard Operating Procedures | Regulatory

Regulatory SOPs

Compliance with the highest ethical standards requires investigators to ensure appropriate SOPs are in place to ensure adequate regulatory compliance. In addition to study specific SOPs the general SOPs contained herein provide a template for regulatory compliance.

SOP NumberTitleLink
1.1 Regulatory Approval for Investigator Led Studies 1.1 
1.2 Study Specific Protocols for Investigator Led Studies 1.2 
1.3 Patient Information Leaflet for Investigator Led Studies 1.3 
1.4 Informed Consent Form for Investigator Led Studies 1.4 
1.5 Regulatory Approval for Clinical Trials 1.5 
1.6 Study Specific Protocols for Clinical Trials 1.6 
1.7 Patient Information Leaflet for Clinical Trials 1.7 
1.8 Informed Consent Form for Clinical Trials 1.8 
1.9 Obtaining Consent for Clinical Trials 1.9 
1.10 Indemnity for Clinical Research 1.10 
1.11 SAE Reporting 1.11 
1.12 Document and Record Archiving 1.12 

Standard Operating Procedures | Clinical

Clinical SOPs

In this section General SOPs for clinical visits to the CRC are described. These SOPs should be supplemented with study specific procedures.

SOP NumberTitleLink
2.1 Research Clinic Scheduling 2.1 
2.2 Research Subject Scheduling 2.2 
2.3 Research Subject Check In 2.3 
2.4 Assessment of the Research Subject 2.4 
2.5 Disposal of Sharps 2.5 
2.6 Handling of Biological Materials 2.6 
2.7 IMP Handling 2.7 
2.8 Arthroscopy 2.8 
2.9 Infusions 2.9 

Standard Operating Procedures | Sampling

Sampling SOPs

The SOPs in this section describe general strategies for collection of biological samples for use in clinical research. These general SOPs should be used in conjunction with study specific SOPs.

SOP NumberTitleLink
3.1 Blood Collection 3.1  
3.2 Cannulation 3.2 
3.3 Urine Collection 3.3 
3.4 Faeces Collection 3.4 
3.5 Sputum Collection 3.5 
3.6 Buccal Collection 3.6 
3.7 Specimen Labelling 3.7 

 

Standard Operating Procedures | General Lab

General Laboratory SOPs

In this section general SOPs for laboratory research are included. These SOPs should complement study specific research protocols.

SOP NumberTitleLink
4.1 Laboratory Rules 4.1 
4.2 Laboratory Safety 4.2 

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