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Our site would like to participate in this study – what regulatory steps are necessary?

Each institution is different. We recommend that you discuss this study with your IRB to understand what approvals (if any) will be necessary at your institution. At its start, this study only collected de-identified data. There is now an optional component to this study that collects Personal Health Information (PHI). Whether you report PHI is up to your institution. If you would like more information, please email us at POCCReport@uabmc.edu.




Have IRB approval from my institution - what are the next steps?

Please let us know that you have IRB approval here, and send your IRB approval letter to our research team (POCCReport@uabmc.edu). You can begin entering cases here




Can I enter in previously diagnosed COVID-19 patients?

Yes. Please enter all patients regardless of when they were identified to be COVID-19 positive. These data can be entered retrospectively (see more below). However, when doing this, please answer the survey questions surrounding the first 12 weeks surrounding the initial COVID-19 diagnosis.




Can I enter in a patient who is off therapy?

Yes. Patients are eligible for inclusion if they have received cancer treatment within the 12 months prior to their COVID-19 infection. Cancer treatment includes chemotherapy, radiation, BMT (blood or marrow transplant) for a malignant condition, GVHD treatment or GVHD prophylaxis for an earlier BMT due to a malignant condition (see BMT below).



Can I enter blood or marrow transplant (BMT) patients?

Yes. Please include BMT patients who were transplanted for a malignancy. BMT patients are eligible to be included if their COVID-19 infection is within one year of their transplant and/or if they were continuing to receive treatment or prophylaxis for GVHD within one year of COVID-19 infection.



Can I retrospectively enter patients who were previously diagnosed with COVID-19?

Yes. Please enter all patients regardless of when they were diagnosed with COVID-19. Data can be entered either retrospectively or prospectively.
However, please pay attention to the timeframe of the questions. There are questions surrounding the time of COVID-19 infection. Then, we ask that you continue to update data up to 12 weeks after the initial COVID-19 infection. This is in order to capture all hospitalizations, treatment modifications, etc. – it is possible that not all of these had arisen at the time you initially entered their data. Don’t worry if 12 weeks have not elapsed yet since your patient’s COVID-19 infection; we will follow up with you. Each month, we will send a data snapshot of the cases you have submitted, including whether or not the 12-week data are complete and a link to find the appropriate survey; this way you can update your case's information as needed.



What about complications that develop after I have entered in my patient’s initial COVID-19 data?

Our team is collecting data from the initial COVID-19 infection through 12 weeks following the COVID infection. When you first enter the patient, please enter whatever data are available. If the patient is already 12 weeks from their COVID infection, indicate that by answering “yes” to the question shown here. If they are not yet 12 weeks from their COVID infection, you will answer “no” to this question. As described above, our team will send you a data snapshot, link to the survey, and whether you have indicated that has been 12 weeks since COVID-19 diagnosis. We anticipate that this will capture the majority of COVID-19 complications. 



If my patient is not yet 12 weeks post COVID-19 infection, do I need to personally save data I entered?

No. Our team will send an email every month with data snapshots of all of your submitted cases. This will include a link to your survey and whether you have indicated that is has been 12 weeks since COVID-19 diagnosis.



Is there risk of linking my patient to the data I enter?

We allow sites to enter a local identifier for each survey; this allows us to help sites keep up with their data. Sites are responsible for keeping up with this local identifier on their end. Clinicians and clinical teams involved in patient care are entering data. This local identifier is separate from our record number and is not linked to any PHI. The Coordinating Center does not maintain any record linkages and has no links for the local identifiers.

However, we have recently included an option for sites to submit limited PHI; if your site is interested in doing so, we will provide the documents needed for this process (contact us at POCCReport@uabmc.edu). If your site does not want to pursue IRB approval to enter PHI, you can disregard the PHI portion of the POCC survey.



How do I keep up with the cases I have already entered?

Within each REDCap survey, you may choose to enter a site-specific unique identifier at the beginning of the form as shown here. This optional identifier cannot have any PHI (i.e., it cannot be a birth date, MRN, or social security number).



What should I do if one of my patients becomes re-infected with COVID-19?

If you have a patient who develops a second infection, please create a new survey form. Please use the same unique local identifier that you used for the first form you submitted for the patient to indicate that it is the same patient. Then answer "yes" to the question shown here regarding second infections.



How should I enter the CBC blood count numbers when submitting entries?

Please enter your WBC, ALC, and ANC in thousands. Therefore, 0.5 would be entered as 500 and 1.2 would be entered as 1200.



Where do I enter a vaccinated patient who becomes infected with COVID-19?

For patients who are infected with COVID-19, but have been vaccinated, please enter them into the National Registry of COVID-19 Cases in Pediatric Cancer Patients (POCC Survey). You will answer “yes” to the question shown here. You can also enter them into the Vaccine registry (below).



Where do I report vaccine information?

Specific vaccine-related data are being collected in the “COVID-19 Vaccine Registry for Oncology Patients” Project (Vaccine Survey), while the COVID-19 infection data are being collected in the National Registry of COVID-19 Cases in Pediatric Cancer Patients (POCC Survey).

Please enter all patients receiving a COVID-19 vaccine (whether they have had a COVID-19 infection or not) in the Vaccine Survey. Sites have the option to use the same local identifier if their vaccine entry is for a patient that they have submitted to the POCC Survey for a COVID-19 infection. If the patient being reported was not already reported in POCC, you can make a new local identifier. This identifier will be important if the patient has not yet received all doses of the vaccine because the Vaccine Survey has 3 parts for patients receiving 3 vaccine doses.


How do I get more information?

Our official POCC Report website is listed on the UAB ICOS website under the research tab. The link is here: https://www.uab.edu/medicine/icos/icos-research/the-pocc-report

Links to the reports and surveys themselves are on this site, along with information about each of the items above. We are also happy to answer any questions. Please email: POCCReport@uabmc.edu


How do I cite the POCC website?

You can site the POCC website using the citation below: 

Johnston EE, Martinez I, Davis ES, Araya B, Richman J, Brackett J, Dickens D, Kahn A, Schwalm Sharma A, Bhatia S, Levine JM, Wolfson JA. The Pediatric Oncology COVID-19 Case (POCC) Report. April 29, 2020. Accessed [today's date]. 
https://www.uab.edu/medicine/icos/icos-research/the-pocc-report