Infant specific-IgE, rhinovirus-C bronchiolitis, and incident asthma in MARC-35
(MARC-35 Research Exam)
Frequently Asked Questions
Q: Should a federal Certificate of Confidentiality be obtained for MARC-35.5 or does if fall under the MARC-35 federal Certificate of Confidentiality as an ancillary study?
A: MARC-35.5 is covered under the MARC-35 Certificate of Confidentiality, which can be accessed here: http://emnet-usa.org/Marc_35/materials/certificate%20of%20confidentiality.pdf
Q: Why does the number of children eligible for the exam at my site exceed the number of children used to calculate my site’s budget?
A: Your budget takes into consideration that 80% of the parent/legal guardians of children eligible for the exam will agree to participate. Of those that agree, 80% will live within close proximity to their enrolling hospital (while the other 20% will have moved away from the enrolling hospital and have their exams done off-site).
Q: What is the difference between the REDCap forms and the hard-copies of the data forms?
A: The Scheduling Form, Research Exam Form, Protocol Deviation Form and AE & SAE Case Report Form are all available electronically through REDCap, or as paper-version appendices to the protocol. The content of REDCap forms and hard-copies is identical. All of the data forms must be entered in electronically in REDCap, but based on your preference and access to internet-ready devices at the time of completion, you may choose to complete the hard-copy forms and later enter them electronically. If the exam room is equipped with an internet-ready device, you may choose to forego the paper forms altogether and complete the Research Exam Form directly in REDCap.
Q: How will my site be notified which participants are ready for scheduling?
A: The EMNet Coordinating Center will contact that parent/legal guardians of the children who are 42-months or older to determine their interest in participating in the exam. If the agree to participant, EMNet staff will collect initial availability (good/bad days and times) and allergy information (so you know what products to avoid in clinic). We will then email you periodic lists of study IDs to communicate who is ready for scheduling. You will then log into REDCap to access the pre-scheduling information on the Scheduling Form and complete the scheduling process.
Q: What is the minimum amount of blood that is needed?
A: The minimum amount of blood required for the study is 5mL (4.5mL for the red-top research blood and 0.5mL for the CBC with differential [lavender-top]).
Q: How does the participant remuneration for the exam actually work?
A: The EMNet Coordinating Center (Massachusetts General Hospital) cuts the checks and mails them directly to the parent/legal guardian. This process typically takes 4 to 6 weeks and is triggered when your site completes both the Scheduling Form and the Research Exam Form in REDCap following the exam. Completion of the online forms notifies EMNet that the visit has occurred. In order to ensure a timely issuing of checks, it is imperative that your site completes the REDCap forms as soon as possible after the visit occurred.