Practical Arrangements Form for the Elation Trial

Practical Arrangements Form for the Elation Trial

ElaTION Trial Site registration form

Practical Arrangements Form for the ELaTION trial

INFORMATION FOR LOCAL PRINCIPAL INVESTIGATORS

ELaTION Trial (The Efficacy and Cost effectiveness of Real Time Ultrasound Elastography in The Investigation Of Thyroid Nodules and the diagnosis of thyroid cancer) study is funded by the HTA and is coordinated by the University Of Birmingham Clinical Trials Unit (BCTU).

The study is led Professor Hisham Mehanna, Chief Investigator.

The lead local researcher for a multi-centre study is the local Principal Investigator.

In the ELaTION trial the role of Local Principal Investigator carries certain responsibilities:

  • Day-to-day responsibility for the conduct of the research
  • Responsible for recruitment into the study at site
  • For ensuring the Research Governance requirements for the centre and the study are met
  • To ensure the agreed protocol is followed
  • Helping care professionals ensure participants receive appropriate care while involved in the research
  • The integrity of records and ensuring they are kept confidential
  • Reporting adverse reactions

All research sites require a favourable opinion from Trust Management that the research may take place. No patients can be approached for consent until this approval is in place.

The ELaTION Office can assist in the approval process if the following information is provided. The Trial Office will complete the necessary paperwork and return to the PI for signature and submission. Trust management approval will require more liaisons between the PI and the Trust R&D Office to gain approval, but again, the Trial Office will help as much as possible.

PRINCIPAL INVESTIGATOR

Name:______

Position:______

Qualifications:______

Department:______

Hospital:______

Address:______

______

Telephone:______Fax:______

Email:______

Practical Arrangements Form

For all centres wishing to participate in the ELaTION Trial:

Please complete all sections below and return to the ELaTION Trial Office.

1. Does your site have Research Nurse Support for the study? ______

If yes, please add contact details at the end of the form.

2. Does your site have RTE equipment? ______

If yes, which brand of RTE equipment is used?

3. Has the PI at your site discussed the ELaTION trial and its requirements with surgical and histopathology colleagues?

4. Are your histopathology colleagues willing to provide tissue samples as described in the ELaTION Trial Protocol.

______

6. Please provide names of Radiologist who will be involved in the ELaTION Trial.

NB: The Radiologist involved in the ELaTION trial is required to attend a RTE workshop as explained in the ELaTION trial protocol.

Name / ROLE

7. Location for research: (to include locations for consent, ultra sound, surgery and follow-up)

Location / Research activity

8. Number of participants expected to be recruited:

  1. For the duration of the study:______

9. Who will be responsible for obtaining consent at site?

(Anyone taking consent should be GCP trained; a copy of the certificate should be held at site and will be requested by R&D and the ELaTION Trial office).

______

______

______

______

10. Is there an independent contact point where potential participants can seek general advice about participation in research?

______

______

______

11. Is there a contact point where potential participants can receive further information about ELaTION Trial?

______

______

______

2. What local arrangements do you plan to make for participants who do not adequately understand English?

  1. Use PALS interpreter
  2. Unlikely to be required
  3. Other

13. Name of Clinical Director (or other person responsible for authorisation of research in the department).

______

______

14. Is there a contact point where potential participants can seek independent advice about participating in the study?

Name/ Job Title: ………………………………………………………………………………

Location: ……………………………………………………………………………………….

15. Is there a clinical trials office or department that BCTU should correspond with to help in the set up of your site? If so, could you please supply a contact name and contact details?

______

______

______

Members of the research team

Participating consultant Radiologist (if not the PI):

Name______

Telephone______

Fax______

E-mail______

Approx. how much time will be spent working on the trial?______

Participating consultant Pathologist (if not the PI):

Name______

Telephone______

Fax______

E-mail______

Approx. how much time will be spent working on the trial?______

Participating research nurse:

Name______

Telephone______

Fax______

E-mail______

Approx. how much time will be spent working on the trial?______

Any other clinician who will be involved in the ELaTION Trial:

Name______

Telephone______

Fax______

E-mail______

Approx. how much time will be spent working on the trial?______

Please return to the ELaTION Trial Office by e-mail, post or fax:

ELaTION Trial Office

FREEPOST RRKR-JUZR-HZHG, Birmingham Clinical Trials Unit (BCTU)

School of Health & Population Sciences, College of Medical and Dental Sciences, Public Health Building,University of Birmingham, Edgbaston, Birmingham, B15 2TT

ElaTION Trial Site registration form

ElaTION Trial Site registration form

Trial Coordinator: Sarah Khan

E-mail: ; Tel: 0121 414 2779 Fax: 0121 415 8871

Coloproctology Trials Team Leader: Dr Laura Magill

E-mail:

Tel: 0121 415 9105, Fax: 0121 415 8871

Please remember to include:

  • Signed and dated CVs for all lead researchers
  • GCP certificates when available
  • Local Trust headed paper (electronic version)
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