Once participants are enrolled, the study team can start to conduct the study and collect the data. The conduct of the study follows the procedures outlined in the study protocol as well as applicable guidelines, regulations, and standards.
A study team can include physicians, nurses, data managers, data entry specialists, pharmacists, laboratory support staff, administrative support staff, statisticians, patient advocates, and others. The team collects information (such as medical history, physical examination results, responses to questions, results of imaging studies) and biological specimens (such as blood samples, tissue samples, genetic tests) from participants according to the schedule described in the study protocol and the procedures described in the study’s Manual of Operations. Each study participant receives a detailed schedule of when data will be collected and what each visit involves; the study team arranges follow up and provides on-going education. Participant information is captured in the study’s data collection system (sometimes using specific forms, called “case report forms”), which can be paper or electronic.
The study team will meet periodically to review accrual, discuss progress, and address any problems. Adjustments to the study procedures may occur, including revisions of the protocol if necessary.
To ensure that study participants are protected and to ensure the integrity of the data being collected, studies are monitored while they are taking place. For instance, researchers are expected to follow applicable guidelines and standards when conducting a clinical study:
NICHD staff may attend "open sessions" to provide the Committee with relevant updates in the field under study that might impact the Committee’s deliberations, to supply additional details on implementation or conduct of the trial, and to answer questions from Committee members.
The Committee recommends continuation, modification, or termination of the trial after each meeting. These recommendations are usually reported to the NICHD, any additional study sponsors, the clinical investigators, any data coordinating centers and the IRBs of participating institutions. through an established information flow. Typically the recommendations are accepted and implemented.
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