| CATEGORY | QUESTION | ANSWER |
|---|---|---|
| Registry/Tx Trial | Are we able to consent fully blind patients to PCG? | Yes, a fully blind patient is able to consent to the registry. The entire consent would have to be read out loud to them. |
| Registry/Tx Trial | Does a fully blind patient need to have an impartial witness sign? | A research coordinator would not qualify as an impartial witness, nor a family member typically. The proper consenting process using an impartial witness for a legally blind research participant, would be to have an impartial witness observe the consent process, such as a subject advocate or someone not affiliated with the research team. Family members are not recommended to serve as witnesses. However, another staff member at your facility who's not associated with research, such as a nurse or medical assistant, would be able to facilitate the role of an impartial witness. |
| Registry/Tx Trial | Can another coordinator serve as an impartial witness? | The proper consenting process using an impartial witness for a legally blind research participant, would be to have an impartial witness observing the consent process, such as a subject advocate or someone not affiliated with the research team. Family members are not recommended to serve as witnesses. However, another staff member at your facility who's not associated with research, such as a nurse or medical assistant, would be able to facilitate the role of an impartial witness. |
| Registry | Is e-consenting allowed for the registry? | Please follow any institutional policies set forth by your facility which allows for consenting of subjects using an e-signature. If you have a policy in place allowing for non-face-to-face e-signature consenting to be used, then you may go ahead and utilize this workflow. An e-signature service, such as Adobe Acrobat or DocuSign will need to be used in order to capture a subject's encrypted identifiable signature and must be compliant with FDA regulations 21 CFR Part 11 to be considered an original signature. Once your REG001-09 ICF template has been modified to include e-signature collection, please submit for sponsor review and then it will need to be resubmitted for WIRB approval prior to being used. It goes without saying, that the informed consent process still remains the same for subjects being consented using an e-signature just as they would be in person. Subjects should be adequately informed about the research, have time to review, be given an opportunity to ask any questions, understand their participation is voluntary, and as before all interactions and processes should be documented accordingly in the subject's consent note. Please be sure the patient also receives a copy of the consent for their personal records as well. |
| Tx Trial | Is e-consenting allowed ? | Please follow any institutional policies set forth by your facility which allows for consenting of subjects using an e-signature. If you have a policy in place allowing for non-face-to-face e-signature consenting to be used, then you may go ahead and utilize this workflow. An e-signature service, such as Adobe Acrobat or DocuSign will need to be used in order to capture a subjects encrypted identifiable signature and must be compliant with FDA regulations 21 CFR Part 11 to be considered an original signature. Once your study ICF template has been modified to include e-signature collection, please submit for sponsor review and then it will need to be resubmitted for WIRB approval prior to being used. It goes without saying, that the informed consent process still remains the same for subjects being consented using an e-signature just as if they would be in person. Subjects should be adequately informed about the research, have time to review, be given an opportunity to ask any questions, understand their participation is voluntary, and as before all interactions and processes should be documented accordingly in the subjects consent note. Please be sure the patient also receives a copy of the consent for their personal records as well. |
| Registry/Tx Trial | What are the steps if a patient wants to withdraw from the Registry? | As long as the patient has given verbal approval stating the desire to be removed from the study, this subject may be withdrawn from REG001-09. #1 Capture in a note to file that the patient has stated he/she has withdrawn. #2 Update the subject's status to "Off Study." Once the subject's status has been updated to off study, an Off Study eCRF will automatically populate in order to capture the reason as to why the subject has been deemed off study. Please complete this eCRF, as well as upload a Note to File documenting the subject's desire to be withdrawn from REG001. #3 Please be sure to complete both registration forms for this subject in Alexandria as well as the Arm and Eligibility eCRFs. These two forms will always need to be completed for all registered subjects, even if the subject withdraws before the start of treatment or is deemed a screen failure. Please refer back to the eCRF training video under Resources to walk you through the process. |
| Treatment Trial | What are the steps if a patient wants to withdraw from a Study? | As long as the patient has given a verbal approval stating the desire to be removed from the study, then this subject may be withdrawn from a study. #1 Capture in a note to file that the patient has stated he/she has withdrawn. #2 Update the subject's status to "Off Study." Once the subject's status has been updated to off study, an Off Study eCRF will automatically populate in order to capture the reason as to why the subject has been deemed off study. Please complete this eCRF, as well as upload a Note to File documenting the subject's desire to be withdrawn from the Study. #3 Please be sure to complete both registration forms for this subject in Alexandria as well as the Arm and Eligibility eCRFs. These two forms will always need to be completed for all registered subjects, even if the subject withdraws before the start of treatment or is deemed a screen failure. Please refer back to the eCRF training video under Resources to walk you through the process. |
| Registry | What are the steps to re-enroll the patient that has formerly withdrawn from the registry? | If the patient is interested in re-enrolling at some point, they will need to be reconsented again due to the original consent being revoked per the study subject. Then you would just simply reactivate this subject's study identification number by updating the patient's status in Alexandria. |
| Regulatory | How do we increase accrual numbers for a specific study? | To increase your accrual number, you'll need to make a request through your IRB of Record. It's with your IRB where this number is initially declared via the study consent. As you approach your listed accrual number, you'll need to make a request to increase that number in order to remain compliant with your IRB. This should simply be done by amending your ICF with the new accrual number, although this process may vary depending on your IRB's policies/procedures. |
| Regulatory | Does an ICF need to be submitted for sponsor approval prior to IRB submission? | Yes, PCG needs to approve consent changes made to your ICF. |
| Alexandria | How can I reset my Alexandria password? | Click here to watch video. Note, the account will be disabled if there are too many attempts with an invalid password. In this case, send email to hq@pcgresearch.org, and ask for your Alexandria account to be re-enabled. |
| Registry | How do I choose the correct arm for my patient? | Click HERE for the Treatment Arm Assignment button on the Registry Study page. Or watch this video. |
| Registry | Are recurrent patients still to be included in the registry study? | Yes, all radiation patients, including recurrent patients, are eligible for registry participation. This information will be collected in the Diagnosis/Baseline and Prior Treatment forms which capture the patient's recurrence status, followed by any radiation/chemotherapy that may've been previously administered. |
| Registry | Patient enrolled in the wrong registry. How do I correct? | To correct a patient that has been enrolled in the wrong registry, simply link/register the patient to the correct registry you want to enroll for proper enrollment. Note: When re-enrolling the patient to the correct registry, please be sure to use the "Search" bar to look up the patient's study ID# when registering/linking the patient to the correct registry, and be sure to finish through the entire enrollment process. Once completed, and the patient is now enrolled to the correct registry, you can then submit a support ticket to request removal from the incorrect registry. |
| Registry | Patient was treated in two different sites; do we need to upload the DICOM files as two separate treatment plans? | Yes, if patient was treated in two different sites, you will need to upload the DICOM files as two separate treatment plans, instead of being documented as a phase 1 and phase 2. |
| Registry | What if a registry patient comes back for more treatment? | If the new treatment is associated to the patient's primary disease at the time of registry enrollment, then you would want to continue to capture any further disease occurrences and treatments as long-term follow-up information in an annual follow-up form. |
| Registry | What if a registry patient comes back to be treated for a different primary disease? | You'll want to link/enroll this patient to their new disease registry in order to start capturing the patient's new diagnosis and treatment information. First, you'll want to link this already existing registry patient to their new registry treatment arm. Please be sure to use the "Search" feature on the Demographics page during the new enrollment process to look up the patient's ID# and link them to the new registry arm. Make sure to continue all the way through the enrollment process and save at the end to properly link the patient to their new registry. Now you have successfully linked your patient to another registry and may begin capturing information regarding their new primary diagnosis. |
| Alexandria | Alexandria is not working properly. There is missing data, and I get an error message when I try to submit a support ticket. | Check to see if you are in the training environment instead of the live system. The training URL is https://pcg-test.alexandria.care/select/studies and the live system is https://pcg.alexandria.care/select/studies. |
| Registry/Tx Trial | How do I resolve an error message on an uploaded DICOM file? | Review this document: DICOM Instructions. It is located on the EDC Training page in the EDC Resources section. |
| Registry/Tx Trial | What do I do if the patient will no longer be following up with treating physician? | 1. Upload NTF in the patient’s chart in the specific time point. 2. Upload deviation form in the Deviation eCRF. This will allow for planned protocol deviation for future follow ups. |
| Registry/Tx Trial | How do I find queries in Alexandria EDC? | Please watch this clip to guide you through the steps. |
| Registry/Tx Trial | How do I add a new dashboard in Alexandria? | This video shows how to add a Discussion dashboard for Treatment Trials only. Click here. |
| Registry/Tx Trial | How do I improve my performance review score for next quarter? | You simply take the TOTAL# of current OUTSTANDING/INCOMPLETE queries on your dashboard (total discussions/queries located on the bottom left corner of your dashboard). You multiply this total by the percentage you are looking to get next quarter. This will give you the number of queries you need to complete before the next quarter to get this score. Example here! |