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Protocol Abstaction FAQ​​​​
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  • ​What is an Initial Abstraction​?


    Receipt of an email from CPM with the version 1.0 protocol document or official permission from CPM serves as the trigger for SIO to perform the initial abstraction process. Information provided in the protocol document will be abstracted into the NCRMS RSPA module.


  • What is the timeline for the Study Information Office (SIO) to process an Initial Abstraction for a protocol?


    5 business days.


  • What is an Amendment Abstraction?


    Receipt of an email from CPM with the protocol document version higher than 1.0 serves as the trigger for SIO to perform this process. SIO will abstract the updated information from the protocol document into the NCRMS RSPA module. If there were any scientific changes to the Arms, Interventions, or Outcome Measures, SIO will contact the CPM to request QC of the information.


  • What is the timeline for the Study Information Office (SIO) to process an Amendment Abstraction for a protocol?


    4 business days.


  • How long does a CPM have to verify the amended information in the N-CRMS RSPA module when a protocol is ‘in CPM Review’?


    5 business days.


  • What does the QC status "In CPM Review" mean during an Initial Abstraction following an NLM Decision?


    The QC status is set to ‘In CPM Review’ during the initial abstraction process. After the initial abstraction, the study waits for an NLM assessment to be completed, which determines if the study is an applicable clinical trial and who is responsible for transferring the record to ClinicalTrials.gov.

    If it is determined that DMID is the responsible party to register and transfer the study to ClinicalTrials.gov, SIO proceeds to send an email to the CPM requesting an NCRMS RSPA Quality Check (QC) for all fields of the abstracted study to ensure it is accurate and matches the protocol document.


    QC Steps:

    • Review, verify and/or edit information in each RSPA Section to ensure it matches the protocol.
    • In each Section after review for QC is complete, select Mark QC Complete.
    • In Section 6 - enter the Primary Completion Date/Type.
    • Click Accept Protocol Information at the top of the protocol record after QC of all sections.
    • Inform the protocol PI and the Manufacturer (as applicable) of pending NLM protocol information transfer.


    The CPM will have 10 or more business days to complete QC. If a Study Initiation Visit (SIV) does not appear to be scheduled yet, the deadline for QC will be 10 business days after the notification is received by the CPM.

    If an SIV has been scheduled, the deadline for QC will be due 1 week prior to the SIV date. Once QC has been completed by the CPM, the QC status is automatically set to "In Final Review" and SIO proceeds accordingly to find if any of the sections have been corrected or updated by the CPM.


  • What does the QC Status "In CPM Review" mean during Amendment Abstractions?


    During an amendment abstraction, if SIO finds any scientific changes or updates in the Arms, Interventions, or Outcome Measures in the new protocol version of the study, SIO sends an email to the CPM requesting NCRMS RSPA Quality Check (QC), specifically for the sections changed in RSPA. Upon receipt of this email, the CPM must follow the same steps taken during the first QC of the NLM Decision. The CPM will have 5 business days to complete QC


  • Why is NCRMS RSPA Quality Check (QC) important for protocol studies?


    QC completion from the CPM is important following an NLM Decision because it ensures accuracy and helps find any discrepancy prior to the submission of protocol information to the NLM prior to subject enrollment.

    However, if the CPM QC completion is delayed, the study will also be delayed from being transferred to the NLM and posting to ClinicalTrials.gov for the first time. Additionally, this also prevents the study from receiving a National Clinical Trial (NCT) number.

    Similarly, QC completion is important after amendment abstractions are completed because it ensures the updated scientific changes are accurate and allows for the CPM to find any discrepancies or last-minute updates that could be addressed prior to the next NLM transfer. Delayed QC by the CPM prevents the study from transferring to the NLM and posting to ClinicalTrials.gov with the updated scientific changes.


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