MRC Clinical Trials Unit at UCL
90 High Holborn
Data Management FAQs
Case Report Forms
a. What CRF version do I use?
This is dependent on the date of assessment/date the event you are reporting occurred and the specific CRF in question. Please see the flowchart and CRF Version History, and check with the STAMPEDE team if you have any further questions.
b. The participant hasn’t had radiotherapy but the Radiotherapy Detail form is listed as overdue on the Form Status Report. What do I do?
The Radiotherapy Detail Form is expected for all participants for completeness of data. If the participant has not had radiotherapy please just specify this on the form by answering the question 'Was radiotherapy given' as No.
c. What do I report on the SOC HT Log?
Only report changes (start, stop or drug change) to SOC hormone therapy on the SOC HT Log. This includes bilateral orchidectomy and any anti-androgens as part of SOC hormone therapy e.g. for slower than expected decreases in PSA. You should NOT report anti-androgens given for disease flare (only needs to be reported on the Randomisation Form, or on the Follow-Up CRF if on Arm L) or any hormone therapy given as treatment for progression (should be reported on Additional Treatment Log).
d. The Pathology CRF is listed as overdue on the Form Status Report. Is this for blood or saliva?
The Pathology form refers to the Saliva Pathology form. Please note that the saliva sample can be taken at any point in the trial and the form expected date for this specific form is just an indication and reminder to have the sample collected.
For participants who have been on the trial prior to 2015, the Pathology Form was used to collect information on the FTA Elute Cards for blood samples (no longer used on the trial). If the participant is eligible for saliva sample collection, the Saliva Pathology Form can be completed instead of the blood Pathology Form, or in addition to if the blood sample has already been taken.
e. My participant doesn't require a Gleason score for eligibility. How do I report this on the Randomisation CRF?
If the participant meets the inclusion criteria without using the Gleason score (please see Eligibility FAQs for further detail), Gleason score can be marked 'Not done' on the CRF.
f. The participant has had toxicities not related to his treatment. Should I still report them on the Toxicity Form?
Yes, all toxicities occurring up until 30 days after treatment stopping should be reported on the Toxicity CRF, regardless of relatedness. Please do not report pre-existing conditions unless exacerbated by treatment.
g. Where do I report concomitant medications/interventions that are not specifically listed on the Follow-Up form?
We only require concomitant medications or interventions of interest to be reported. If the medication or intervention was in relation to a toxicity, please ensure the toxicity has been reported.
h. My participant has co-enrolled to an observational clinical trial. Does this need to be reported on the Co-Enrolment CRF?
No, only interventional trials require completion of the Co-Enrolment CRF.
i. Our hospital lab provides results in a different unit that provided on the form. How do I report this on the CRF?
If possible please convert to the units stated on the form. If not, clearly indicate what units have been used to report the value.
j. How do I report a toxicity that is not listed on the Toxicity CRF?
Refer to CTCAE v.4.03 available via the STAMPEDE website, and provide the body system category, toxicity name and correct grade in the space provided at the bottom of page 2. If not listed in CTCAE, do not report on the CRF.
k. The participant was randomised with incorrect details. What do I do?
Please contact the trial inbox (email@example.com) urgently to inform us of which details are incorrect. Please also ensure you have written the correct details on the Randomisation CRF. We can then update our database with the correct details.
l. I don’t understand this data query. What do I do?
Please contact a Data Manager if you require clarification regarding any data queries.
m. The data query is asking something not on the form. What do I do?
In some cases, additions to the CRFs are chased retrospectively where important. This is the case for the Biopsy Specimen details on older versions of the Baseline Form. Please contact a Data Manager if you require clarification regarding any data queries
n. I have answered these data queries before. What do I do?
Please attach a copy of the previously completed DCFs or answer the query again.
o. I am receiving data queries for a participant who has transferred. What do I do?
We may not have been notified of the transfer. Please ensure you have completed the first part of the Transfer form and liaise with the new centre to complete the second part of the form. Please also ensure we are sent a copy of the transfer form to enable us to make the necessary changes to our database so that the new centre receives queries after the date of transfer
p. I am receiving data queries for a participant from before they transferred to my site?
Once a participant transfers, the new site is responsible for managing all the participant’s data. If you are receiving queries relating to the period prior to the participant’s transfer to your site, refer to the notes from the randomising centre. If it is not possible to resolve through the notes, please contact the randomising centre for the required information.
q. The follow-up assessment was delayed and is after the expected visit date on the Follow-Up Schedule. Should I report as a visit for this week number, or the next?
This depends on how close to the next week in the Follow-Up schedule the date of the delayed assessment is. If the follow-up assessment date falls between two corresponding week numbers in the Follow-Up schedule (e.g. in the middle of weeks 36 and 48), or if the participant is due to visit again soon as part of the Follow-Up schedule, report the assessment date as the visit for the previous/delayed week number that was delayed.
If possible, please try to book the next visit back on schedule. If you are still unsure on how to report a delayed assessment, contact the CTU for further guidance.
If the delayed assessment is close to the next scheduled visit, report as the next visit (e.g. delayed week 36 visit is close to expected week 48 visit, report as week 48). Send a Follow-Up CRF reporting the earlier visit as missed.
r. I do not have a follow up schedule for my randomised participant. What do I do?
If the participant was randomised after 5th September 2016 please contact the STAMPEDE inbox (MRCCTU.firstname.lastname@example.org) with the participant ID and ask for the Follow Up Schedule. This can be posted to you or emailed via Galaxkey.
If the participant was randomised before 5th September 2016 we can no longer generate Follow-Up Schedules. We can provide the Form Status Report which details when participant visits are due. If you would like a copy of this please contact the STAMPEDE inbox (MRCCTU.email@example.com) with the participant ID and ask for the Form Status Report for scheduling purposes. This can be posted to you or emailed via Galaxkey.
From Protocol v19.0 onwards, we will require receipt of the participant’s Consent Form before generating the Follow-Up Schedule. This allows us to personalise the schedule based on the participant’s consent to trial sub-studies.
s. The participant wasn't seen in clinic, but had a follow-up via telephone/chemo clinic, how do I complete the Follow-Up Form?
On versions 13.0 onwards of the Follow-Up Form select the appropriate option for Q2 Trial follow-up type. If the trial follow-up type is not listed, answer 99 and specify the follow-up type on the line provided.
t. How long are participants followed up for?
Participants are followed up according to their allocated follow-up schedule, please refer to Table 1 in the protocol that details these. After 5 years on trial they are followed up annually until comparison closure.
u. Do participants who have experienced disease progression who have started second line treatment still require metabolic profile taking at weeks 24, 48 and 104?
v. The participant missed the metabolic profile tests at the specified follow-up. What do I do?
There is a 12 week window to take the metabolic profile tests i.e. if the test was missed at the time of the specific follow-up it can be completed up to 12 weeks afterwards. If this is the case, please update the Follow-Up CRF after the tests have been done and resend the form. The tests can also be taken 12 weeks before the follow-up date and can therefore be taken beforehand as well if this is better for the participant.
w. If a participant has completed their standard LHRH therapy and not on any research treatments, do we still need to report toxicities?
Toxicities should be reported until 30 days after permanently stopping LHRH given prior to progression, after which reporting is no longer required. Please make sure the stop date of LHRH is reported on the SOC HT log. Please note that toxicities still need to be reported if the participant is still receiving research treatment.
x. If a participant has completed research treatment, do we still need to report toxicities?
Toxicities should be reported until 30 days after permanently stopping research treatment, after which reporting is no longer required. Please note that you need to submit an End of Treatment form to confirm the permanent stopping of research treatment. Also, please note that toxicities still need to be reported if the participant has not progressed and SOC treatments e.g. LHRH are still being given.
y. If a participant is on second line treatment but still receiving their LHRH, do we still need to report toxicities?
No, toxicities do not need to be reported once second line treatment has been started.
z. Are 6 month LHRH injections permitted?
LHRH is a SOC treatment, therefore this is down to the discretion of the investigator.
aa. Is a castrate level of testosterone required to report PSA progression
A castrate level of testosterone is only required where the participant is still on HT.
When a participant is on hormone treatment, we want to know that it is definitely working before saying HT has failed. The best way of knowing HT is working is a low testosterone level. The CRF includes guidance (<50ng/dl or <1.7nmol/L).
ab. The clinician has added anti-androgens to the participant’s hormone therapy. Is this PSA progression?
This depends on the reason for starting anti-androgens and what trial arm the participant is randomised to. If the participant is on a research abiraterone or enzalutamide which cannot be taken with AA, then the participant must stop abiraterone and enzalutamide and this will should be recorded as starting second line treatment and considered progression. If the participant was started on AA as change in their SOC HT (to dual-androgen blockade) which is permitted for participants allocated to arms A, H and K this would not be regarded as progression and does not need to be reported as such.
ac. My participant has started LHRH for progression, where do I report this?
All treatments for progression should be reported on the additional treatment log. LHRH is an available option on version 13.0 of the Additional Treatment Log.
ad. How do I find out the progression value?
You can access the PSA Progression Value Calculator here: http://www.stampedetrial.org/centres/tools-training/calculation-tools/
ae. The PSA Progression Calculator won’t accept the PSA test date. What do I do?
Please follow the calculator instructions and check that the test dates are between randomisation and 24 weeks post-randomisation. If you continue to have problems, please contact the STAMPEDE team.
af. How do I report biochemical progression?
When a participant’s PSA first breaches their progression value a confirmatory PSA should be taken within 3 months to confirm biochemical progression. Biochemical failure should be reported on the Progression Log once confirmed. The date of progression should be the date of the first PSA that breached the progression value.
ag. The PSA of a progressed participant has risen again. Do I need to report this as a new progression?
Please only report the first time the participant's PSA rises above the progression value.
Quality Of Life
ah. When do we stop completing Quality of Life Forms?
QOLs should be completed for five years after randomisation or until progression, whichever is sooner. From Protocol v19.0 QOL data collection is being reduced, please refer to Table 33 in Protocol v19.0 and the protocol specific training.
ai. The QOL Form on the website requires a password. How do I get access?
Please contact the STAMPEDE team for the username and password.
Have another question or looking for more information? why not check out the STAMPEDE Training Suite for the training slides detailing information on STAMPEDE.
MRC Clinical Trials Unit at UCL