Patient's who screen postive or are known to be postive for SARS-CoV-2 ( COVID-19) prior to enrollment, are not to be enrolled in the EpiBioS4Rx Study. You may screen the subject but they would be a screen failure due to their COVID-19 diagnosis. If a patient develops COVID-19 during the 2 year follow up period, we recommend that no in-person testing should be completed, and instead another method be used to complete follow up.

Please contact UCLA to discuss your situation if a previously enrolled subject is diagnosed with COVID-19.

It is important to note that EpiBioS4Rx is a two-year study and follow-up visits compromise the majority of the two years. Therefore, each site should plan accordingly to complete the follow-up visits.

If a patient is not able to travel to your site to conduct a follow-up visit that includes a blood draw, every attempt should be made to complete the visit. This may entail a research team member traveling and visiting the patient. If the patient will be coming back to your medical facility in the future for other appointments, aim to complete the blood draw/follow-up visit at that time.

With new restrictions in place at each site due to COVID-19, we ask you to follow your local research guidelines on in-person follow up and plan your visits accordingly. The EpiBioS4Rx study is still requiring that the follow up period continue until D730, however this may need to be completed using other methods such as phone or video calls.

If the patient is cognitively appropriate, it is suggested that you approach the patient for consent and go over the study with them, including the follow-up visits. If the patient refuses to be a part of the study, discuss alternatives and see if they would be willing to be a part of the study if certain procedures were not conducted. If this is not sufficient, ask if the data collected from their previous visits can be kept for the study.

Before discharge:

• Provide a letter at discharge that contains the schedule of future study visits and descriptions of each evaluation the patient will undergo

• Speak to the patient and/or their family about what is expected of them for the study

• Reiterate that you will keep in touch with them, and you would like them to contact you if they have any questions or if any seizure activity occurs

• Maintain a master calendar of all the patients and their follow up visit dates. This is especially useful when you have numerous patients enrolled at your site

After discharge:

• When getting close a follow up visit window, check the patient’s EMR to see if any appointments have already been scheduled at your site. Try doubling up on that day so it is less hassle for the patient and your team

• Contact the patient and/or family by phone at least 1 week before the visit window opens

• Educate the patient again about the study’s goals and the evaluations they will undergo

• Develop an understanding of the patient’s current situation and what options are available to complete the visit. For patients at inpatient rehab facilities, see if transport can be arranged, schedule a stop-in visit at their rehabilitation facility, or if necessary broaden the window for the visit

• Obtain a copy of EEG if one was performed on patient as a result of the seizure

• Request if possible that a MRI be done with the EpiBioS4Rx protocol

  • • If not, collect any imaging that goes along with the patient’s ER stay (unscheduled MRI/CT)

• Complete or ask your MD to complete the Epilepsy Confirmation Clinic Interview Form (located in REDCap)

• If the patient will be seen as an outpatient by an Epileptologist, this form can be completed at that time

• All data should be entered into REDCap as an Unscheduled Visit

• Outpatient EEG and MRI scans should also be uploaded to the IDA

Request an EpiBios4Rx LONI User Account Request Form from LONI, and complete the form. Select your needed access levels and send the form to data.coordinator@loni.usc.edu You will receive an email from LONI with a username and temporary password. The email will also have instructions on how to create an official password.

If you look at the top right of the REDCap logon page you will see a message, "If you are having trouble logging in, please contact Support" with a hyperlink for support. You may also email support@ini.usc.edu to have your password reset. UCLA is unable to assist with this effort in resetting passwords.

The screen # is an automatically assigned number for your patient determined by REDCap. This number is solely used during the screening process when you complete the Initial Eligibility Form on REDCap and you are contacting UCLA for approval to consent. The Study ID is the main ID in the study, and it is assigned by UCLA once you have enrolled a patient. The study ID is used in both the REDCap and LONI IDA databases.

In order to make sure the dataset is as complete as possible, please try to put the best answer possible. If no answer is available, please leave a comment in the comment log for the specific field explaining why no answer is available.

An AE or SAE that is a consequence of any research procedures during the protocol's research activity (for example, lab draws for research at day 90) should be reported. For TBI-related AEs, the AE should be reported for anything that potentially could affect the incidence of seizures in the Site PI’s professional opinion. Death requires reporting as outlined in the Protocol.

Some examples of potential reporting AE/SAE requirements after enrollment include:

• • Cardiac arrest

  • New Stroke

  • Uncontrolled bleeding during a research blood draw

  • Brain bleed from Depth EEG

  • Tract hematoma from the standard of care EVD

  • Death from any cause

The following medicatons should be recorded in this form:

• • All the medications the patient was taking before their injury (prior)

  • All medications administered to the patient during Day 1-7 (concomitant)

  • After Day 7, only anti-epileptic drugs (AEDs) (concomitant)

Go to https://ida.loni.usc.edu/login.jsp. Click on the button INSTANT FREE SIGNUP. Follow the instructions on the website to create your username and password. Once the registration process is complete, email data.coordinator@loni.usc.edu to request your account to be linked with the EpiBioS4Rx project. Please include your full name, username, title, site name, and PI name in the email.

The IDA will only accept .edf and original DICOM files. Please ensure that the file types being uploaded are accepted by the IDA. Please note that if you receive an error message and your select "Submit", the file/sequence with the error message will not be uploaded.

With regards to the DICOM files, it is common to receive a "DERIVED" error message. The the IDA will only accept original (PRIMARY) files. Secondary (DERIVED) files, which were processed in some way by the acquisition system, will not be accepted. If you are receiving an error message, such as "DERIVED", for a sequence that is not part of the EpiBioS4Rx protocol (e.g. color map sequence), go ahead and select "Submit". When finished with the upload, please review to ensure that all the key sequences were uploaded. If you are receiving an error message for a key sequence, please contact data.coordinator@loni.usc.edu.

To receive access to My Dashboard, please follow the steps indicated in the response to "How do I create an account for REDCAP?" (see above)

On My Dashboard you will find:

• EpiBioS4Rx Regulatory Documents (EpiBioS4Rx clinical, imaging, EEG, and biosample protocols)

• EpiBioS4Rx Training Documents (REDCap case report forms, REDCap tutorial, LONI IDA upload tutorial, Persyst tutorial)

• EpiBioS4Rx Follow-up documents (template follow-up letter, patient contact form, study events template, telephone script)

• Meeting information for our weekly teleconference calls

• Recordings of our past weekly teleconference calls

The MRI Day 1-18 scan is a key component of the EpiBioS4Rx study, so in general please keep the feasibility of obtaining an MRI scan in mind when screening and enrolling patients.

If the patient is not able to complete the MRI scan due to their medical condition, please notify the UCLA coordinating team and aim to complete the MRI scan as soon as the patient is stable and before they are discharged. If the patient had a moderate TBI and you anticipate the patient being discharged before Day 18, please obtain the MRI scan before they are discharged or schedule it as an outpatient MRI. If the Day 1-18 MRI scan was obtained out of window, please upload the MRI scan to the IDA and enter the data into REDCap as an unscheduled MRI visit.

If you can't find a suitable answer to your question or if you have any additional questions/concerns, please contact the UCLA EpiBioS4Rx team

It is important to note that EpiBioS4Rx is a two-year study and follow-up visits compromise the majority of the two years. Therefore, each site should plan accordingly to complete the follow-up visits.

If a patient is not able to travel to your site to conduct a follow-up visit that includes a blood draw, every attempt should be made to complete the visit. This may entail a research team member traveling and visiting the patient. If the patient will be coming back to your medical facility in the future for other appointments, aim to complete the blood draw/follow-up visit at that time.