Research

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Study Conduct Phase

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Protocol Development
Study Closeout and Analysis

 

While patient enrollment and data capture are underway the trial must be continuously evaluated.

Patient Screening and Enrollment

Seek permission to approach potential subjects

Conferring with the clinical team caring for a potential participant prior to approaching the child and family can help to ensure there is no interruption in clinical care or potential issues that would make approaching the family for consent inappropriate.

Screen and enroll subjects

The screening log documents and tracks all potential subjects that were considered and/or screened for the study. The subject enrollment log documents, tracks and follows the progress and status of each enrolled subject through the study process. Screening and Enrollment log templates are available through EQuIP.

Document informed consent

The Consent Library always contains the most up-to-date consent. Informed consent must be documented on a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy is to be given to the person signing the form. Unless otherwise approved by the IRB, a copy of the signed consent form is to be placed in the medical record if the study involves medical interventions, to ensure the safety of the patients who participate in research. Informed consent must be obtained before the initiation of any screening processes performed solely for the purpose of research.

Protocol Development
Study Closeout and Analysis

 

Data Collection

Collection of participant data

Data collection encompasses a wide range of information gathered for a study and may occur at many time points throughout the research study. Collecting data may begin with pre-screening and recruitment and continue through trial termination. Correctly dating and timing study tests and samples is extremely important when conducting clinical research.

Assessing adverse events

It is the responsibility of the PI and licensed clinicians on the study team to monitor study subjects for adverse events during an interventional trial. The IRB, FDA, DSMB and sponsor are each likely to have unique reporting requirements. It is the Investigators responsibility to understand and comply with these requirements. Boston Children’s complies with all applicable local, state, and federal regulations that pertain to reporting requirements. These regulations require that the following be reported: Unanticipated problems that involve risks to participants or others; Suspension or termination of IRB approval of research; and serious or continuing noncompliance with regulations or the requirements of the IRB. Learn more about reporting adverse events

Protocol Development
Study Closeout and Analysis

 

Clinical Trial Oversight

Study team meetings and communication

Updating research staff or caregivers for subjects enrolled in your study is courteous and helps to keep staff engaged and supportive of your research. A regular meeting ensures time for the study team to plan, bring forward study questions, work through logistical issues, data review, etc. The study coordinator or research nurse typically prepares the agenda with the PI and takes the meeting minutes and distributes them to the study team members. Communicating with the statistician as the study approaches target enrollment is critical in preparing for data analysis. Regular review of data can identify deviations and workflow improvements

Monitoring

The purpose of monitoring is to assure adequate protection of the rights of human subjects, safety of all subjects, and the integrity of the resulting data submitted to the FDA. During the study monitoring provides for continued training and education of the study staff; reviews the progress of the study; verifies that data collected is accurate.

Amendments

Throughout the lifespan of a clinical trial, there are likely to be amendments to the protocol. It is important to insure that the most current copy of the protocol is available in the clinical area where study subjects are cared for should a staff member need to refer to the protocol. Amendments may result in changes to the Informed Consent Document, the Manual of Operations, and the resource manual for the clinical unit.

Protocol Development
Study Closeout and Analysis

 

Reporting Trial Progress

Annual IRB report

In accordance with current federal regulations, the IRB must review the risk/benefit ratio for protocols at least annually. The IRB will contact you when it is time for your annual review.

Data Safety Monitoring Meetings/Interim Analyses

Compliance with the Data Safety Monitoring plan is critical for the safe conduct of interventional trials. In addition, planned interim analyses must occur as defined in the protocol. 

Send Study Tracking Sheet (STS)

Study tracking sheets ensure the appropriate assignment of patient care charges to the insurer and study-related costs charged to other funding sources, helping Boston Children's remain compliant with state and federal mandates and third party payer policies.

Protocol Development
Study Closeout and Analysis

 

Request Services
* To access this service you must be on the Boston Children's network or logged in through VPN.

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