Contacts
| PIMDA Study Administration: c/o Brenda Hooper/Cliff Wyatt HealthCare21 Communications Ltd Oakfield House, Springwood Way Macclesfield, SK10 2XA, UK
|
Tel: +44 1625 503479 Fax: +44 1625 612683 Email: admin@PIMDA.eu |
| PIMDA Data Entry Helpdesk | Tel: +31 162 520 964 (08:30-17:00 CET) | Mob: +31 629 092 481 (18:00-22:00 CET) Email: info@gezondheidsmeter.nl info@curavista.nl martine.vanhouten@curavista.nl |
Eligibility clarifications
- Patients being treated for existing mould infections (suspected or otherwise) are excluded.
- Patients with a relapse of AML who will receive a remission-induction course are eligible to be entered into the study. (Re-induction for refractory or relapsed cases is mentioned in Appendix B ‘Chemotherapy of AML and MDS’).
- Patients with ALL undergoing chemotherapy (not for SCT) are not eligible for inclusion.
- Patients given high-dose chemotherapy and autologous stem cell transplant are not eligible for inclusion.
- Patients undergoing a reduced intensity conditioning regimen are not eligible for inclusion.
- FLAMSA patients are eligible, because the chemotherapeutic preface usually results in a prolonged and deep neutropenia similar to that seen in remission-induction of AML/MDS.
eCRF FORMS
REMINDER: You can save forms and come back later to complete the entries (if you ‘Submit’ the form, then data cannot be changed).
- Demography forms: questions concerning antifungal prophylaxis (first line and subsequent lines) have been separated out from the Demography forms, and will now be available to you only at 12 weeks after the start of chemotherapy.
- Names of forms and when they will become available to you are listed below:
| Form name | Content | Available | COMMENT |
|---|---|---|---|
| Screening Criteria | New patient information | Enrolment | |
| Demography StemCellTransplant | Demography information | After ‘Screening’ form is submitted | Only available if patient is eligible based on screening criteria |
| Demography AML & MDS | Demography information | After ‘Screening’ form is submitted | |
| Prophylaxis | Initial and ongoing antifungal prophylaxis | 12 weeks after date of starting chemotherapy. | The prophylaxis questions were originally contained within the Demography form, but have now been split out. |
| Initial Diagnostic Workup | Diagnosis of IMD
Treatment of IMD Initial diagnostic work up |
7 days after ‘Screening‘ form is submitted | You can start to add data when the patient develops IMD, or you can wait until 12 weeks after starting chemo and then add all data at the same time.
If the patient does not develop IMD in the 12 weeks after starting chemo, only the first 3 questions will be available to you. If the patient develops IMD later than 12 weeks after enrolment, data should NOT be entered as it is outside the timescale of this study. |
| Additional diagnostics obtained | Ongoing treatment of IMD
Additional diagnostic work ups |
After ‘Initial Diagnostic Workup’ form is submitted | This form will only be available if your patient developed IMD in the first 12 weeks after starting chemotherapy. |
| Week 12 after inclusion | Information on neutropenia | 12 weeks after starting chemotherapy | |
| EORTC classification | Comment on EORTC classification | 12 weeks after starting chemotherapy | |
| Final outcome (6 months) |
Patient status at 26 weeks | 26 weeks after starting chemotherapy |
CHECKING DATA ON THE eCRF
- Login on the pimda.eu site.
- On the left hand side of the screen there is an orange tab linking to ‘pimda.eu’. Click on it.
- Again on the left hand side, white tabs become available; click on the ‘Patients’ tab.
- In the centre all your inclusions are listed as sequenced IDs. These sequenced IDs are clickable, so pick the one you want to focus on.
- On the left hand side another set of tabs become available; click on the ‘History’ tab.
- In the centre all submitted forms of the CRF become available; click on the form you wish to review.
How to add a note to a patient record
- Log in with your username/ password at www.pimda.eu
- Click on ‘PIMDA.EU’ on the left of your screen.
- Then click ‘Patients’ and the list of all your enrolled patients appears.
- Choose the patient that you want to add info on > Click on that patient.
- Click on ‘Notes’ on the left of your screen.
- Then click ‘Add’ to write the note (remember to include the date of your note). It does not change any information in the forms, but you can track any special circumstances, or errors made.