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Study Implementation

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Protocol Development
Study Implementation
Study Conduct Phase
Study Closeout and Analysis

 

Now that the protocol has been developed, the study team must prepare for the study’s launch and finalize the workflow of the clinical trial.

Clinical Trial Oversight

Establishing the operating guidelines that will determine how the administration of the clinical trial will proceed is crucial for the successful launch of the trial.

Develop study logs/tools

Templates are available for study tools such as delegation of responsibility logs, training logs enrollment logs through EQuIP.

Create electronic shared folder for study documents

Establishing a shared electronic folder such as a SharePoint site can assist the investigator and the study team in maintaining organized study documents that are accessible to all team members. The Clinical Research Information Technology (CRIT) team can help create electronic shared folders for study documents.

Create Manual of Operations (MOO)

A study Manual of Operations (MOO) is a document or a compilation of documents that describe in complete detail the science, methods, and procedures for implementation of a clinical research study. The MOO is an essential tool that promotes accuracy and consistency in study implementation across different study sites, and across all research staff over time. It serves as the primary reference guide used for staff training prior to study start-up, throughout study implementation and for staff training whenever turnover occurs. Finally, the MOO serves as the SOP reference that study monitors and auditors use during QC site visits or audits. The study MOO may be maintained in hard copy or electronic format.

Finalize Tracking Sheet

Boston Children's has two systems for paying for related tests/procedures.

Client code
The client code is ordinarily used for charging lab tests, if lab tests are study related and not for routine clinical care. If there are exams, imaging, and lab tests, a study tracking sheet is more appropriate. 

Study Tracking Sheet (STS)
The study tracking sheet (STS) is developed by Patient Financial Services (PFS) and is arranged before the clinical trial agreement is signed. The STS outlines all tests, procedures that could be billed to the study and is sent to the Patient Financial Services on the day of the study visit to track research-related charges. Research-related charges should never be billed to insurance. The only charges that should be billed to insurance are those tests/procedures that are part of routine clinical care.

Schedule recurring study team meetings

Throughout the course of implementing a study, there may 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.

Protocol Development
Study Implementation
Study Conduct Phase
Study Closeout and Analysis

 

Data Management

Planning your data capture and storage is an essential component of study implementation.

Confidentiality Plan

Developing a plan that outlines how the study team will ensure the protection of subject data is an important step in preparing to launch a research study.

Examples of common issues to consider are:

  1. Are case report forms de-identified?
  2. Where is the informed consent stored? (Usually the original informed consent is maintained in the study file, with a copy in the medical record. Study files should be secured in a locked file cabinet in a locked office).
  3. Will subject data be shared with clinicians?
  4. Are safety lab results being forwarded to the child’s pediatrician or specialty physician? (The study team should decide which research data will be accessible to the child/participants primary care providers, and which information is study specific).

A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical, and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, to identify information or characteristics of a research participant. Review Certificates of Confidentiality.

Finalize Database Management plan

Having the proper database for your research study is important. The CRIT team will consult with an investigator and ensure the proper database is selected for a particular research study and build the database.

Develop Case Report Forms (CRF’s) & Data Storage

The ICCTR and ET/IT Center have many useful guidelines and templates to assist investigators and their study team.

Protocol Development
Study Implementation
Study Conduct Phase
Study Closeout and Analysis

 

Clinical Management Planning

Participants enrolled on clinical trials must receive the same high-quality care found elsewhere in the Hospital. Communication and coordination with the clinical care team improves study compliance and supports patient safety.

Develop resource manual for clinical unit

Developing a study’s resource manual for clinical staff that will be caring for participants is important. Working with the unit educator regarding how to best communicate this information to bedside caregivers and where the manual will be housed on the unit is an important responsibility of the study coordinator or research nurse. A one page summary of relevant study information (“Fact Sheet”) for direct care giving staff can help insure study compliance. It can be placed at the bedside or in the study subject's medical record for access to all direct care giving staff.

Create study orderset

A clear set of study orders is essential to ensure accurate study implementation. There are locations in the hospital that use paper orders, others that strictly use PowerChart and still other areas that work from a combination of paper and electronic orders. Working with a nurse from the clinical area where your study will be conducted to develop order sets is highly recommended.

Confirm study drug in pharmacy

If your study involves the use of an investigational agent, it is important to confer with the Investigational Pharmacy early in the planning of your study. Prior to study launch, check to insure that the research agent is available in the Investigational Pharmacy and that the pharmacist has no final questions or issues that need to be resolved prior to implementation.

Protocol Development
Study Implementation
Study Conduct Phase
Study Closeout and Analysis

 

Study Launch and Recruitment

Actively planning your study launch and screening and enrollment strategies can help bolster accrual.

Set date for trial launch

Establishing a date for trial launch imposes a tentative deadline that all members of the study team are working against and often proves useful. The date can always be adjusted

Establish procedure for screening and enrolling patients

The importance of detailed planning for a system for screening and enrolling study subjects can not be over-emphasized. Informing your physician and nurse colleagues about your research study is important. They can often help you accrue study subjects. They can help you work through the logistics of launching your study in a clinical environment.

Announce trial launch

Reviewing your research study and the proposed timeline for study launch with departmental faculty, colleagues and members of the multidisciplinary team can serve to engage colleagues in the identification of study subjects and support of your research. Research nurses and study coordinators frequently prepare and deliver study-related education to staff in the clinical environment to ensure they are aware of the details of the study and how they can assist.

Study implementation meetings

As the time approaches to launch your research study, it is important to schedule at least one meeting that includes the study team and members of ancillary services i.e. Investigational Pharmacy staff, nursing unit representatives that will be involved in helping with study implementation, study coordinators and research nurses. This meeting can be used to answer questions, clarify roles in an effort to ensure that all personnel involved in the study are prepared and "on the same page".

Protocol Development
Study Implementation
Study Conduct Phase
Study Closeout and Analysis

 

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

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