Develop and implement the study
Researchers still have groundwork to do even after they receive permission to begin study.
Development: Finalizing study plans and procedures
Before a study can start recruiting or enrolling participants, the study procedures, training, and documentation must be finalized. The study procedures are developed based on the study protocol. The study team usually develops a Manual of Operations (also known as Standard Operating Procedures document) for the study. This manual provides detailed steps in regards to study recruitment, enrollment, administration of informed consent, use of study forms, and documentation of study data. To maintain data reliability, it is important for study team members, especially those collecting data, to follow the study procedures as written.
The study team develops and engages in training for the study during this stage. This process may involve learning interviewing skills, becoming well-versed in the study goals and how to administer informed consent, understanding how to document the data collected, and defining what to do in case of an adverse event.
Screening procedures and eligibility criteria for participants are also finalized during this step. Some studies seek participants in certain age ranges, within a specific region of the country, or with a certain type of symptom or disease. To focus the research study and make sure that the data collected truly inform the study questions, the researcher develops criteria to screen the potential participants before they can be enrolled.
Study forms are also developed at this time. Study forms may be case report forms, questionnaires, or other data-collection or data-tracking instruments.
Implementation
Implementation of the study involves recruiting participants, screening participants to ensure they meet eligibility criteria, getting informed consent from participants, enrolling the participants, registering participants, and (if necessary) randomizing participants into their appropriate study groups.
Recruitment and screening
In the study’s protocol, the researcher determines the target participation accrual (necessary number of participants overall and for each site) and the recruitment procedures.
The study will make efforts to recruit participants—that is, tell people about the study. This involves posting the study on certain Web sites, such as clinicaltrials.gov, posting notices within certain geographic regions, alerting health care providers about the study, and involving support or advocacy communities in spreading the word about the study. A participant may also learn about the study through reading newspapers, journals, or from his or her own health care provider.
After a participant has been recruited into the study, then he or she must go through the screening process, as defined in the study protocol to determine if that participant is truly eligible to join the study. This screening usually involves answering a series of questions about background and sometimes medical history.
Consent & Enrollment
If a study participant is eligible for the study, then he or she needs to be formally enrolled in the study. This requires a participant to review and sign an informed consent document.
One of the primary safeguards for study participants is that they are informed about the potential risks, benefits, alternatives, and responsibilities of the clinical trial before they agree to participate. When a potential study participant understands the risks, alternatives, and responsibilities, he or she formalizes the decision to participate by communicating with the study investigator or representative and by documenting the agreement in writing. The interactive process of receiving information, asking questions, and indicating agreement is known as the consent process.
Resources for developing and implementing the study
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