As summer starts winding down in the South, and winter continues to dump snow on us in the North, we hope everyone has had a safe and enjoyable holiday season. In the upcoming months we look forward to activation of new sites in Canada, Chile, Qatar, and Israel and continuing to work with you in 2013!
On February 21st an Update Memo was sent to each site providing updated trial documents. Please remember to…
1) Follow the instructions outlined in the Update Memo for each document
2) Submit all applicable documents to your REB/IRBs
3) Retain an original copy of the REB approval and updated document
4) Forward your REB/IRB approvals to the EMPOWER Coordinating Centre(CC)
5) Implement the update!
ECGs and Patient Diaries
Please scan de-identified copies of ECGs and patient diaries, attach a completed Supporting Documents Form, and forward to the EMPOWER CC. Click here for a revised Supporting Documents Form. Keep all originals on file at your site as a source document.
When forwarding copies of ECGs, please do the following:
- Remove all personal identifiers including name, date of birth, health file or medical record number by striking out this information with a black china marker
- Add the 9-digit subject study ID number
- Add the word “mother” or “infant” to indicate who the ECG was conducted for
- Add the word “baseline” or “study end” to indicate the time point of the ECG
- For infant ECGs, add the age (days/weeks of life at time of ECG AND gestational age at birth) and sex
Study Medication Inspection Logs
When a new shipment of study drug is sent to your site, you have been receiving an EMPOWER Study Drug Receipt email with two attachments: Study Medication Inspection Log and Study Medication Receipt Instructions. Please remember to complete the attached Study Medication Log, which contains a printed list of the drug kits sent to your site. Forward a copy of the completed log to the EMPOWER CC, and keep the original on file at your site.