
EC Trial Finder Data Submission - FAQ and Troubleshooting
Frequently Asked Questions
1. How should I list the trial arms?
In the current set up of EC Trial Finder data entry we ask you to list different cohorts, but not arms. Cohort is a group of individuals who share a common trait e.g. cancer type and/or molecular marker. Please list each cohort (if several) separately.
Arms allow different interventions to be compared. A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, is an arm. This level of detail does not need to be recorded in EC Trial Finder, please just provide the cohorts. You can add details of arms in the ‘Trial notes’ section and also by providing a URL link to external source.
2. What are the three molecular marker categories (Gene/protein, Pathway and Genomic/DNA repair markers) in the molecular marker eligibility section?
In this section you should list any molecular stratification markers listed as part of the patient eligibility criteria as per trial protocol. Only inclusion criteria should be listed and they should be listed for each cancer cohort separately.
These could be:
- Gene/protein markers (e.g. KRAS) and then any additional attributes like "over-expression" can also be added
- Pathway markers, meaning criteria that includes word "pathway" (e.g. RAS pathway or KRAS / RAS / RAF pathway)
- Genome level or DNA repair markers (e.g. MSI high, hypermutated tumours)
3. How do I list molecular marker eligibility when there are several different attributes for the same gene (BRAF mutation and amplification) or several genes with different number (FGF1, FGF2 etc)?
Please list each separately as a new marker e.g. BRAF mutation, BRAF deletion. Similarly, if there are several genes with different numbers like FGF1, FGF2 you should add them each as individual markers.
4. What I can do when the IRAS number is wrong/wrong trial comes up when I search with IRAS?
Please email ectrialfinder@cancer.org.uk so this can be immediately corrected, and you can proceed to add the new trial. Please provide the IRAS and trial title details.
5. What should I do when a cohort is on ‘hold?
You can choose not to add that cohort yet/remove the cohort if it is not currently recruiting patients and add it only when it is open for recruitment. If you think it would be useful for people looking for trials to be aware of this cohort already, even that it is on hold/suspended (for example if it is likely to open soon) then feel free to add it, but add in ‘Site Information’ section ‘Site notes’ make a note that this cohort is currently on hold and any details about the likely opening.
6. Who should add the new trials -is it the Lead site’s responsibility?
No, any Site can add a new trial when it opens at your Site as we don’t want the lead site to block any other multi-site trials advertising this trial. We follow ‘first come first add’ principle. You will always start the adding a new trial process by performing an IRAS number search, to ensure there is no duplication of effort and if any other site has added the trial details already you will find them.
7. What is a cohort?
In the current set up of EC Trial Finder data entry we ask you to list different cohorts. Cohort is a group of individuals who share a common trait e.g. cancer type and/or molecular marker. Please list each cohort (if several) separately aka each cancer type that the trial is recruiting. Please select the cancer type listed in the trial protocol using the ECTF cancer categories (see glossary). If the trial recruits multiple cancer types, please add these as separate cohorts.
8. What are ‘site notes’?
This note should be relevant to your specific recruitment site, not the whole trial. These notes are meant to be published in EC Trial Finder to aid patient matching and give additional useful information about the trial or recruitment status.
For example:
- "Only adult patients recruited at our site", "Only paediatric group 0-18 years olds"
- "Cohort X on hold - uterine/endometrial cohorts only"
Please do not add any personal or patient data. The note should be maximum one sentence and very brief.
9. What are ‘cohort notes’
These should be at a trial level, not only to your individual site. This note will be published on EC Trial Finder to aid the clinician or user to find a suitable trial for their patient. Please do not add any personal or patient data. These notes can include anything that you think is helpful for patient matching, finding a suitable trial or for recruitment purposes.
For example, you could add:
- A note that the recruitment status is likely to change frequently, or the cohort is likely to close/open soon.
- Any additional patient eligibility criteria that might be useful, for example, the specific cancer sub-type
- Further details about the specific eligibility criteria e.g. patients with prior immunotherapy treatment
10. Eligibility Age - what age range should I add, my site’s age eligibility or the trial level age eligibility?
Please give the trial-level age eligibility (as per trial protocol), not one specific for your site. You can add site related age eligibility notes to "Site notes".
11. What if I do not have ‘primary recruitment contact’ details and this is stopping the trial going live/published?
Please copy the PI’s details to this section
Troubleshooting
1. I cannot progress to next page when adding a new trial and clicking ‘save and continue’?
Please scroll up on the page and there will be an error message flagging what is blocking you to progress. Please address the error and then try again.
2. I am being told to refresh and make my changes again
Only one person can make changes on your site’s 'My trials' page at any one time. If another person has made changes since you opened this page, then you will have to refresh to see these changes before you can edit any trials. This is to make sure all information is captured and is not accidentally overwritten by two people being on the page at the same time.
3. I’ve added a new trial, but my changes didn’t save. Instead, there is a new trial with the same IRAS number that I didn’t create
This would happen if you searched for an IRAS number which had not yet been added, at the same time someone else was adding the same trial with the same IRAS number. Only the data from the first person to add the trial will be saved. To continue adding your data, search for the IRAS number again and select ‘add my site.’ This is expected to be a rare occurrence so if this has happened, please contact ECTF admins so that we can consider if a more sophisticated solution is required in future.
4. I’ve edited my information from one of my trials but now I can’t see the changes e.g. add a new cohort
This would happen if another person opened the same page while you were adding data and then saved the page after you, only their changes are saved and you will have to make yours again. This is expected to be a rare occurrence so if this has happened, please contact ECTF admins so that we can consider if a more sophisticated solution is required in future.