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During 2 days of in-person meetings, the study team carefully considered and discussed the criteria for identifying signs and symptoms as major, and thus potential candidates for inclusion in the measure.
At these meetings the study was presented by the principal investigator (TTH) and all questions could be discussed and answered.
At these informative meetings the study was explained in detail.
During all telephone and face-to-face contact meetings, the study research assistants will ask participants if they have experienced any AEs and log these.
During the community meetings the study staff made a brief presentation on the purpose and objectives of the study; answered questions and sought input and suggestions from the audience, which were then incorporated into the study wherever necessary.
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There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives.
At the conclusion of this final meeting the study participants gave verbal affirmation that they agreed with and would follow the behaviors outlined in the Best Practices List.
At that meeting the study will be described, outstanding questions answered and the potential participant asked to sign the consent form which will be countersigned by the member of the research team.
Figure 3 shows the participation of frontline government staff in meetings in the study's 3 districts: ASHAs and Anganwadi workers were present in over 60% of meetings, and auxiliary nurse midwives (ANMs) attended an estimated 50% of meetings.
Parental written and informed consent often necessitates parents attending meetings where the study can be explained and this is difficult to achieve.
The committee set up 22 meetings during the study period.
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