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
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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
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