Question Set A: Primary intent is a public health practice or a disease control activity. • Epidemic/endemic disease control activity; data directly relates to disease control needs • Routine disease surveillance activity; data used for disease control program or policy purposes • Program evaluation activity; data is used primarily for that purpose • Post-marketing surveillance of efficacy and/or adverse effects of a new regimen, drug or device • Activity is purely administrative (e.g., purchase orders or contracts for services or equipment) and not related to research
Question Set B: Activity is research but does NOT involve identifiable human subjects. Activity is research involving collection/analysis of data about health • facilities or other organizations or units that are not individual persons or • Activity is research involving data and/or specimens from deceased persons or • Activity is research using unlinked anonymous data or specimens. All (1-4) of the following are required: 1. No contact with human subjects is involved for the proposed activity; Data or specimens are/were collected for another purpose;
3.
No extra data/specimens are/were collected for this purpose;
4.
Identifying information either was not obtained or has been removed so that data cannot be linked or re-linked with identifiable human subjects.
Chapter 11
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Making Monitoring and Evaluation Systems Work