DOWNTIME PROCEDURES FOR COG INSTITUTIONS DURING COG NETWORK OUTAGE The following procedures should be followed during a COG Network Outage. The network outage may also be associated with outages of the COG Operations and Data Center e-mail or phone systems. In the absence of other instructions, COG institutions should operate according to the following procedures. Communications from COG to COG Institutions: COG Public Website: www.childrensoncologygroup.org Communications about the outage will be posted on the COG Public website. The COG Public website is hosted on a separate server from the COG Members site, so will be active even with the Members website down. Mass e-mail communication Mass e-mail communications during the outages will be sent using the distribution list used for the weekly FROM THE SDO mass e-mail. Please note that the message may come from an e-mail address in the Group Chair s Office at the Children s Hospital of Philadelphia. Please forward e- mail communications to your institutional colleagues if you doubt that they received them directly. Communications by COG Institutions to COG Operations and Data Center During Network Outage: Phone numbers should be contacted in the order they are listed for the department taking into account the respective time zones. Statistics and Data Center 1. COG SDC Monrovia staff contact information (Pacific) 1) Steven Jong, 626-241-1528 2) Smita Subramaniam, 626-241-1623 2. COG SDC Gainesville staff contact information (Eastern) Research Coordinators email Phone # Charlotte Wood* Cwood.cog@gmail.com 352-273-0573 Dina Willis* Dwillis.cog@gmail.com 352-273-0562 Susan Conway* Sconway.cog@gmail.com 352-273-0559 Lisa Kozak (Program Assistant) 352-273-0556 *Please address all URGENT enrollment and callback randomization e-mails to all three of the research coordinators listed above to ensure a prompt response. Page 1 of 5
Statisticians Mini Devidas Mdevidas.cog@gmail.com 352-273-0551 COG Administration 1. 215-590-6354 (Eastern) 2. 626-241-1577 (Pacific) Study Development Office (Pacific) 1. 626-241-1570 2. 626-241-1583 3. 626-241-1680 Phase 1 Operations 1. 626-241-1566 (Pacific) Phone Numbers Outside COG Office Hours During an Outage or When COG Phones are Down as a Result of an Outage Statistics and Data Center 1. 352-262-0639 2. 626-244-4914 3. 626-399-9777 COG Administration 1. 626-827-1908 2. 626-235-3776 Study Development Office 1. 626-975-6867 2. 626-548-1597 3. 626-827-0299 Phase 1 Operations 1. 626-660-7066 2. 626-226-6024 COG IDs: During the network outage, COG will not be able to generate an official COG patient identifier or Biopathology Center identifier. If one is immediately required for study enrollment or specimen submission, the institution should use the following as a temporary identifier: Institution NCI ID-Protocol ID-Accession number. For example, if the Children s Hospital of Philadelphia needs to create a temporary patient id for an enrollment on AAML1031, the ID would be PA076-AAML1031-01. If they enroll a second patient on the same study during the outage, the ID would PA076-AAML1031-02. Sites Page 2 of 5
should obtain an official COG ID once the website is restored and contact the respective study s research coordinator to reconcile the temporary ID with the official COG ID. Non-Urgent Patient Enrollments, upfront Randomizations, Callback/Late Randomizations: If possible wait until the COG web site is back on-line for any non-urgent enrollments and randomizations. Urgent Patient Enrollments and upfront Randomizations: If a subject MUST be enrolled during a website outage, please follow the procedure below. However, every effort should be made to delay enrollment when possible: 1. Check the Clinical Trials Support Unit (CTSU) website to confirm that your institution s site registration status is set to approved for the study of interest. 2. Complete a PAPER COPY of the ELIGIBILITY CRF and email it to all three of the Research Coordinators listed above. If your institution does not have scanning capabilities, please fax your completed study-specific Eligibility CRF to (352) 392-8162. If you do not have a copy of the required eligibility CRF, take the following steps: a. Attempt to obtain a copy from another COG member institution b. Obtain a copy of the eligibility section from the protocol (a copy should be on file at your institution) and complete the information on the copy from the protocol section itself. 3. The institution will need to complete the Eligibility CRF form in erde once the COG members' website is back up. 4. A request must then be submitted to the respective study s research coordinator requesting a correction of the date of enrollment in erde. A COG Research Coordinator will send email confirmation that eligibility requirements have been met and acknowledge the intent to complete the study enrollment process once the COG web site is back up. Reminder: enrollments and randomizations will need to be completed again via the erde once the member s website is online again. For the ALL classification study AALL08B1, please be sure to keep copies of the Eligibility CRF and Specimen Transmittal Form which has to be included with specimens sent to the COG ALL reference laboratories (Flow laboratory, Banking). Urgent Callback/Late Randomizations: Hand-write the required field answers on the study-specific Callback/Late Randomization CRF and email it to all three of the Research Coordinators listed above. If your institution does not have scanning capabilities, please fax the completed CRF to (352) 392-8162. Page 3 of 5
Randomization will be done by an SDC statistician and you will be notified of the treatment assignment via email. Callbacks/Late Randomizations for the frontline ALL trials require that End induction Risk Assignment on the Classification study AALL08B1 be completed first. If all but end of induction MRD data and Day 29 marrow response have been submitted on AALL08B1, the research coordinators will be able to determine the risk assignment if copies of all the other data submitted, together with the MRD data and Day 29 marrow response are emailed/faxed to them. Reservations: As a measure to ensure that capped-accrual studies do not over enroll, it will not be possible for institutions to obtain new reservations form the COG Members website during the network outage. Furthermore, institutions may not enroll on studies that require a reservation if they were not holding a reservation at the time of the network outage. It must also be understood that once the Members website is restored, institutions must refrain from making new reservations until an e-mail communication is sent by COG informing them that institutions may proceed with accessing the reservation system. This will allow the Data Center time to reconcile enrollments with reservations that expired during the outage. Dose Assignments on Phase 1 Studies: If a study enrollment has a dose assignment that is normally populated on the enrollment receipt, the dose assignment will need to communicated by phone with follow-up confirmation e-mail. Institutions should contact the numbers listed above for Phase 1 Operations if the study is a COG Phase 1 Consortium Study. Data Submission: It is understood that institutions will be unable to submit routine data to erde during a COG Members website outage. Exceptions will be recorded for any phase 1 data submission due during the outage to ensure that the delay is not counted against institution on their institutional performance report card. Sample shipments: Sample shipments to laboratories can be sent utilizing a generic specimen transmittal form if the study - specific form is not available. If the study has a study-specific shipping form in erde, that form should be completed when the COG website is restored. If the subject only has a temporary COG ID and the samples don t need to submitted immediately, the institution should try to delay shipment until the website is restored and an official COG ID can be obtained. Page 4 of 5
Drug Supply: Investigational drug supply through the NCI s Pharmaceutical Management Branch (PMB) should not be impacted by a COG Member s website outage. If there are any concerns about a drug order from the PMB institutions should contact the PMB directly at 301-496-5725. If there is a concern about the order of investigational drug supply through one of COG s industry partners please contact COG Administration at one of the numbers listed above. AdEERS Reporting: The AdEERS application is not connected to the COG Members website so institutions ability to submit AdEERS reports should not be impacted by a COG Members website outage. Institutions will be expected to meet AdEERS reporting requirements during a COG Members website outage. Please note that the NCI AdEERS application can be accessed directly at: http://ctep.cancer.gov/protocoldevelopment/electronic_applications/adeers.htm Protocols and Protocol Questions: Institutions should have an available copy of all COG protocols open at their site. If an institution does have difficulty accessing a protocol during a website outage or has a protocol related question, the Study Development Office should be contacted at one of the numbers listed above. IRB Approvals: The Clinical Trials Support Unit (CTSU) s ability to process IRB approvals and regulatory documents will not be impacted by a COG Members website outage. If an enrollment must be completed during a COG website outage, prior to completing the faxed enrollment, the institution must check the CTSU website to confirm that the institution s site registration status is set to approved for the study of interest. Page 5 of 5