The Role of the Research Nurse and Trial Coordinators. Duncan Colyer Senior Research Nurse Peter MacCallum Cancer Centre

Transcription

1 The Role of the Research Nurse and Trial Coordinators Duncan Colyer Senior Research Nurse Peter MacCallum Cancer Centre

2 The Mysterious Role of the Research Nurse and Trial Coordinators

3 so, why the mystery?

4 Is the mystery in our name? Research Nurse Trial Coordinator Clinical Research Nurse Clinical Trial Coordinator Study Coordinator Nurse Researcher Research Sister

5 Is the mystery because of how we work? Clinical Trials Units themselves vary, depending on: The type of trials being conducted; surgery, radiotherapy, drug trials or patient experiences Where they are based; in a specialist facility or hospital The phase of trials being conducted Their structure; tumour streamed or not The number of trials and amount of staff at a the facility Each of these will determine the role of the research nurse

6 Is the mystery because of the variety A Clinical Trial Team can include: of roles we do? Research Nurses Clinical Trial Assistants Ethics Submission Specialists Research Nurse Consultants Administration Assistants Study Coordinators Data Managers Laboratory Assistants Chemotherapy Trial Specialist New Trial Feasibility Coordinators Or, all these roles can come under that of the Research Nurse or Trial Coordinator

7 And so, how to debunk this mystery? Domain by domain (adapted from Hastings, 2007)

8 Duncan s Domains of the Research Nurse Clinical Practice Study Management Coordination and Continuity of Patient Care Patient Advocacy Contributing to the Science

9 Clinical Practice o Report actual and potential adverse events and Serious Adverse Events o Providing direct patient care, including appropriate referrals o Provide teaching to patients and their families regarding the study o Performing study related procedures (ECGs, phlebotomy, sample processing) o Ensuring the accurate recording of meaningful and reproducible data

10 Study Management o Comply with ICH Good Clinical Practice (GCP) o Participate in site visits, audits and inspections o Perform quality assurance to ensure data integrity o Participate in study development, including study tools and Case Report Forms (CRFs) o Budget development for new protocols subsequent amendments o Participate in patient recruitment, including attending MDMs

11 Coordination and Continuity of Care Coordinate patients study visits and schedule study procedures according to protocol Coordinate referrals to appropriate healthcare services Be a resource and provide trial information to associated healthcare providers Educate other staff about trials Answer patient inquiries and concerns

12 Patient Advocacy o Facilitate the informed consent process o Support the patient in their decision to take part in the trial, or to withdraw their permission o Be a member of the Institutional Review Board to review trial related material for all trials

13 Contributing to the Science o Serve as a resource to new investigators and other members of the study team o Serve as an expert in a specialty area (i.e. grant reviewer, editorial board, presenter) o Disseminate clinical expertise and best practices related to clinical research through presentations, publications, and/or interactions with nursing colleagues o Mentor junior staff

14 Despite this clarity to our role, what type of people are we? We have attention to detail We like to have continuous relationship with patients We like to be at the forefront of evidence based treatments We like to utilise a wide range of skills We can work both autonomously and as part of a much wider team We like the hours! And we like to solve the mysteriousness of our profession!

15 Any Questions?

16 References Hastings, C. (2007). Putting clinical research nursing on the NIH roadmap. Paper presented at the American Academy of Nursing Annual Conference; Washington, DC.