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Biomarker Screening Pilot: Biomarker Screening Pilot:

Biomarker Screening Pilot: - PowerPoint Presentation

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Uploaded On 2018-03-15

Biomarker Screening Pilot: - PPT Presentation

CRF Completion guidelines Overview General CRF completion Patient details header Registration CRF After registration Almac Test Request Form Blood CRF Color Sample Requisition Form Screening and ID: 652262

crf registration form sample registration crf sample form details stampede screening blood send header date patient completed biomarker randomisation

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Presentation Transcript

Slide1

Biomarker Screening Pilot: CRF Completion guidelinesSlide2

Overview

General CRF

completion

Patient details header

Registration CRF

After registration

Almac

Test Request Form

Blood CRF

Color Sample Requisition Form

Screening and

Randomisation

Slide3

CRFs should always be signed and dated

CRF without a signature or date of completion cannot be acceptedChanges should be initialled and dated

CRFs should be completed by trained and delegated staff

Boxes should be ticked clearly and unambiguously

General CRF completionSlide4

Patient details header

S-STAMPEDE CRFs will have an orange header to distinguish from STAMPEDE CRFs

Header

should always be fully

completed

Errors in the patient header will prevent CRFs from being entered

Please

double check that header details are entered

correctly and consistently with details provided at registrationSlide5

Registration CRF

Q1-4 must be answered Yes for patient to be eligible

Registration CRF to be completed by Research team at registration centre

Ensure header details are correct – any errors will prevent subsequent forms from being entered Slide6

Registration CRF

Please see guidance for anti-androgen and ADT timelines

Please see Protocol section 4.3.1 for further details on hormone therapy timelines for Biomarker Screening Pilot eligibilitySlide7

Registration CRF

Date sample planned to be sent to biobank must be

within

10 weeks of starting anti-androgens and 8 weeks of starting LHRH.

Please note blocks should be requested and ready to send to lab as soon as possible after registration.

Please see Protocol section 4.3.1 and Stratified STAMPEDE Sample Manual for details on sample selection

Refer to Additional Research Consent Form V2.0 for these answersSlide8

Registration CRF

Complete after confirmation of successful registration to pilot

Call the MRC CTU Registration and Randomisation line and specify on the call that you are

registering to the STAMPEDE

Biomarker Screening

Pilot

Tel: +44 (0) 20 7670

4777 (Monday – Friday 0900-1700)

Slide9

After Registration

MRC CTU will send

a

Registration Report

to the registering Research Team via

Galaxkey

to confirm the Registration ID and other key details for the

patientPatient identifiersLatest date to send sample to labLatest date to randomise patient

Send a copy of the Registration CRF to the MRC CTU and retain one copy at site.

Slide10

Almac Test Request Form

Enter patient’s registration ID and date of birth, ensuring they match the registration details

Provide details for first point of contact.

Almac

will send any questions regarding the data or tissue sample to the contact listed here

Enter the 3 digit STAMPEDE centre number hereSlide11

Almac

Test Request Form

If two blocks have been provided, provide both block IDs here

Form can be signed by any delegated member of the research team

Please ensure this is the same date provided on the registration CRF QC1

Send a copy of the form to

Almac

Diagnostics with the tissue

samples and retain

one copy at

siteSlide12

Blood CRF

The Blood CRF should be completed at the time of the blood sample, after registration.

A Blood CRF will be included in the lab kit with a space to record the patient’s registration ID, instead of the trial ID and treatment arm.

Blood samples taken after randomisation should be reported on the normal CRF with the trial ID and treatment allocation.

Slide13

Blood CRF – Registration sample

The questions to be completed are clearly marked on the CRF

Tick Registration

timepoint

.

- If registration sample is done, there is no need for another sample

prior

to starting trial treatment

All registered patients should be metastatic

- Tick M1

Blood sample is required for biomarker screeningSlide14

Blood CRF – Registration sample

Complete questions related to sample collection

Make two copies of CRF and send to addresses listed on CRF

Question 5 is blanked out in registration sample CRFSlide15

Sample Requisition Form

The

Sample Requisition

Form should be completed at the time of the saliva sample, after registration.

Complete the Registration ID

Date of saliva sample

Follow the instructions on the form, ensuring that the barcodes match

Please make

2 copies

of the form: include one copy in the saliva sample pack and send the other to MRC CTU.Slide16

Screening and randomisation

Biomarker screening results will be sent to Research Teams via

Galaxkey

In the pilot study, biomarker screening results are not required to be known before randomisation

Complete any outstanding STAMPEDE screening procedures and randomise the patient as normal, on V15.0 of the Randomisation CRF

Slide17

Web:

www.stampedetrial.org

Email

: mrcctu.stampede@ucl.ac.uk

MRC Clinical Trials Unit at UCL, Stratified STAMPEDE Team

Stratified STAMPEDE Data Manager

Stratified STAMPEDE Trial Manager

Carly Au

T: +44 (0) 207 670 4794

Chris

Wanstall

T: +44 (0) 207 670 4882

Contact Us