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| PROCEEDeNEWS |
| UPDATES AND INFORMATION ON THE PROVENGE REGISTRY OF MEN WITH ADVANCED PROSTATE CANCER |
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PROCEED eNEWS is an e-mail information source for study centers participating in
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PROCEED (PROVENGE Registry for Observation, Collection, and Evaluation of Experience Data).
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REMINDER: UBC IS DENDREON'S REPRESENTATIVE FOR THE PROCEED REGISTRY AND
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SHOULD BE YOUR FIRST POINT OF CONTACT FOR ANYTHING NOT RELATED TO MONITORING.
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| THANK-YOU TO SITES |
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We are pleased to announce that as the majority of patients have completed at least 3 years of follow-up
for the study, we are now beginning to plan the closure of the PROCEED registry. It has been a pleasure
to work with you and your staff over the past years. We here at Dendreon and UBC are appreciative of
your contributions to this study, as we are well aware of the long commitment this study has been for you
and your patients. We are pleased to share that we have reached 4,500 patient-years of data and nearly
600 patients who, having received Provenge several years ago, are still alive today. Thank you again for
all you did at each of your sites, as the information gained from this study is so important in furthering
our understanding of Provenge. We could not have done it without you!
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| Final Patient Study Visits |
- Please continue to conduct patient study visits and collect data per protocol through 1/16/2017.
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- Reschedule all patient study visits and procedures scheduled to occur after 1/16/2017 to occur prior to this date to obtain final data for subjects, if possible.
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- Contact any patient who does not have a study visit scheduled before the end of day on 1/16/2017 to inform him the study will complete and close, conduct the last follow-up visit, and thank him for his participation. This will act as the last follow-up visit in the study. Then complete the Off-Study Form using the Off-Study reason of: "Other— Study Completion."
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- If you are unable to contact a patient by 1/16/2017 despite all efforts, please send the message via registered letter as soon as possible. The date the letter is sent will be the last follow-up visit in the study. Then complete the Off-Study Form using the Off-Study reason of: "Other— Study Completion."
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| The deadline for all data entry is 1/31/2017. |
- As soon as possible, and no later than 1/31/2017, please record all final study data on the required case report forms for monitoring and verification by your CRA.
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Principal Investigator Review
& Sign-Off of Data in EDC |
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The principal investigator is responsible for reviewing and signing off on all data in EDC prior to database lock. Principal Investigators will need to confirm access to EDC to complete eCRF sign-off
by January 16, 2017. The investigator should ensure that his/her user name and password is current in the EDC system in order to log in and complete the signature process. If you are having trouble logging
in, confirm that no institutional firewall(s) are blocking access. If further assistance is needed, contact your CRA, Lead Clinical Data Manager, Kathy Aasmundstad at kathy.aasmundstad@UBC.com, or the
UBC Support Personnel at 877-511-5541.
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| Please do not hesitate to contact the UBC Data Management Team or your CRA with any questions you may have regarding the investigator signature process prior to database lock. |
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Upcoming Monitoring Visit
& Preparing for Your Site Close-Out |
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As you all know, we are following all subjects until they either expire, withdraw consent, or the study ends. And as study completion and closure is fast approaching, it is very important we continue
regular follow-up with subjects, document any new ACI regimens, and collect PSA values for Amendment #1 subjects.
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Interim Monitoring Visits will continue to be very important as they help prepare for the closure of the
registry at each of your sites. Therefore the CRAs will continue to reach out to you to conduct onsite IMVs
and remote IMV reviews in the upcoming months. In preparation for these visits, please be sure that EDC is up
to date (best practice is to enter the visit data the day of the visit or the next day) and all queries
answered as soon as you receive them. Please also make sure all your Regulatory items are up to date and filed in
your Investigator Site File and that any required copies are sent to your Clinical Trial Specialist at UBC. Once
everything is in place at the IMV, it will make our final study closure visits run much smoother.
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If all of your subjects have gone off study, you will be contacted by your Dendreon CRAs to schedule a
Site Closure Visit prior to database lock and study closure. If you are not contacted by your Dendreon CRA,
please feel free to reach out to your CRA or the UBC team as well.
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If you have any questions as we approach the end of the study, please contact either your Clinical Trial
Specialist from UBC or your Dendreon CRA.
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| Helpful Tips to Avoid Queries |
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Please review the following reminders to help ensure all required CRF forms are accurately completed for all patients coming off study.
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- For patients who have not expired and are currently on study, the "Last day on study" response on the Off-Study Form must be completed using the date of the last follow-up visit. For the Off-Study reason, please select "Other" then indicate "Study Completion." Please refer to the "FINAL PATIENT STUDY VISITS" article above for details.
- For patients who went off study due to death, the "Last day on study" response on the Off-Study Form must be the same as the "Date of Death" response on the Death Summary form.
- If the Off-Study Form response is "Yes" for "Has the subject begun a new anti-cancer or chemotherapy treatment – or has a previous treatment been modified – since the last contact?" then the ACI form must have a treatment with start or stop date on the date of the last follow-up visit.
- All patients must have a completed SAE form when coming off study. If an SAE form was previously completed nothing needs to be done. However, if no SAE form was previously created, an SAE form must be completed. Enter ”No” responses to the two lead-in questions asking if patient experienced an SAE or a CVE if the patient did not experience a reportable SAE/CVE during the study.
- The response to the SAE/CVE question on the Off-Study Form must agree with the data entered on the SAE form(s).
- All forms for patients must be Saved and Locked.
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| Data Queries |
| Data queries may be issued following final data entry. Please resolve any data queries within 3-5 days of receipt. Final queries will need to be resolved within 24 hours. |
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| Final Payments |
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Please send any study-related pass-through cost forms and invoices such as study closure fees, local IRB fees, and archiving fees to UBC at
amy.l.davis@UBC.com as soon as possible so they may be processed for payment. It is important we receive
the completed pass-through cost forms and invoices in a timely manner so you can ensure your site receives payment prior to study closure at your site.
As always, patient study visits will be paid following receipt of verified CRFs. If you require any assistance with payments, please contact
kathy.shillington@UBC.com.
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Share the PROCEED eNEWS
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The newsletters are a great motivational and educational resource for your study staff. Please forward this e-mail to them. And please remember,
downloaded eNEWS issues must be filed in your Physician Reference Manual.
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Confidential - For PROCEED Study Center Staff Only - Not for Distribution
Outside PROCEED Study Centers.
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©2016 Dendreon Corporation.
All rights reserved. November 2016.
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