Spotlight on SOPs - A Bright New Future

December 2022 Issue

Author(s):

  • Rana Leed, MPH, Human Research Education Manager, Clinical Research Resources Office

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Introduction

Welcome to the Spotlight on SOPs! There will be a new column in the CR TIMES with a focus on the upcoming Standard Operating Procedures. With the release of the SOPs guiding our work in human subjects research, each month we’ll review a specific SOP and highlight some of the best practices from that SOP. This month’s Feature Article will introduce this new column, describing why these SOPs were created, and the benefits of using these new resources to guide the conduct of your important research.

 

What is an SOP, and how will it function?

That’s a great question!

There are just as many definitions of what a SOP is as snowflakes in the sky. We’ll use a general definition:  SOPs are a set of written policies and procedures designed to achieve uniformity of performance and ensure compliance to applicable policies, regulations, and recommendations. Basically, SOPs are a set of documents that provides guidelines for conducting successful, compliant, and overall excellent human subjects research.

These SOPs will guide research that is within a specific scope - but it should be recognized that all research teams can benefit from reviewing these for best practices. If the research that you are doing does not fit into this scope, then the SOPs are still recommended as a good foundation for anyone working with human subjects. If you are unsure if any of the SOPs apply to you, contact the BMC Clinical Research Network (CRN) for guidance.

The SOPs will specifically guide clinical research studies that target BMC patients, use BMC patient data, or utilize BMC facilities and/or services.

  • BMC patient: any individual with a clinical encounter generating a BMC-specific medical record
  • BMC patient data: patient data that is derived from BMC medical records and/or systems
  • BMC facilities: clinical or non-clinical space owned or operated by BMC
  • BMC services: a unit or group operated or managed primarily by BMC staff

 

What does an SOP look like?

Also a great question!

There are currently fifteen SOPs, and all follow the same general format. Each SOP will have the following sections:

  • Purpose/Objective: Explains briefly what the SOP will include and the intent
  • Scope: Includes which studies the SOP applies to as referenced above
  • Responsibility: Provides information on whose responsibility it is to follow the procedures in the SOP
  • Procedures: Contains the primary information and details of how to complete the procedure or process
  • Definitions, References, and Resources: Includes additional details and links, but not all SOPs will have information in these three sections

 

Are there any training requirements?

Another great question!

Yes, there will be training requirements.  CITI modules will be available tentatively in summer 2023 and will be based on a “Read → Complete Knowledge Check → Acknowledge” system. There will be two tiers of training requirements based on the type of study category. Again, all research teams and staff members are encouraged to review all SOPs. The SOPs will also be incorporated into educational trainings and resources that are currently offered by the Clinical Research Resources Office. You can also request custom training if you feel your team or department would benefit from targeted learning.

  • January 1, 2024: all new studies targeting BMC patients, utilizing BMC facilities and/or services, or using BMC patient data will require completion of training prior to IRB approval
  • January 1, 2024: required within 90-days of employment start date
  • December 31, 2024: existing clinical research investigators and staff are encouraged to complete

 

How do I access SOPs and what do they actually include?

Another great question! 

These research SOPs will be available and effective on January 1, 2023, and will be accessible to both BMC and BU Medical Campus researchers. The SOPs will be posted within INSPIR II, the electronic IRB research application system. To access the SOPs, you will need to log in to INSPIR II, and click the (?) Help Icon in the upper-right hand corner of your INSPIR home page. This will open a separate window that includes links to the SOPs.

When the final SOPs are posted and available to access, we will send out an announcement to all INSPIR II users that will contain detailed instructions and screenshots that will show you exactly how to find and download each SOP.

Covering a wide range of topics, the SOPs include guidance on how to complete some of the daily activities of a research team, and also address overarching structural activities.


Institutional Clinical Research Policies and Guidance Library

Serve as an overarching index of SOP documents. Also describes general research responsibilities and requirements.

Research Training

Provides detail on available training to conduct clinical research. This includes required training and additional training that may be applicable based on the roles delegated to investigators and research staff.

Research Team Competency

Describes an investigator's oversight responsibilities to ensure that all research team members have been trained on their delegated tasks and are competent to perform those tasks.

Quality Management

Provides best practice recommendations for conducting self-assessment monitoring of study documentation and processes.

Site Monitoring

Describes the purpose and procedure involved with a Sponsor or Lead Team monitoring visit. It describes the activities by the research team at study site from the time the monitor requests to schedule a visit, until all follow-up activities have been completed.

External Audit Preparation

Describes the purpose and types of external audits that can be expected within clinical research, and the preparations and procedures for those audits.

Essential Research Documents

Describes what constitutes essential documents that make up the regulatory and participant files, and provides guidance in their management throughout the course of a study.

Delegation of Authority and Responsibilities

Describes an investigator's oversight responsibilities to ensure that all research team members have been trained on their delegated tasks and are competent to perform those tasks.

Participant Recruitment

Ensure that the PI and research team members assisting in the conduct of clinical research are informed about their obligations, responsibilities, and available resources related to participant recruitment.

Informed Consent Process

Describes the requirements for conducting the informed consent discussion and documentation of informed consent for non-exempt research with human participants that involves prospective interventional or observational research and prospective consent from the participant or (LAR) or parent/child.

Case Report Form Completion

Describes the process for use of CRFs, including recording data, corrections to data, responding to queries, and requirements for signing CRFs.

Adverse Event Monitoring, Assessing, and Reporting

Supports the PI and research staff in identifying, assessing, documenting, and reporting all adverse events, serious adverse events, and unanticipated problems.

Protocol Deviation Reporting

Provides guidance on the proper reporting of deviations that occur during the research that are not part of or are inconsistent with the IRB-approved protocol and study plan, BMC/BU Medical Campus HRPP Policies & Procedures, or federal regulations.

Participant Withdrawal

Describes the process for a research participant’s voluntary withdrawal from a study completely, an investigator’s decision to terminate the participation of a participant before the study is completed, and early discontinuation of a study intervention.

SOP Management

Describes the development of centralized SOPs, the review and approval process of SOPs, and procedures for maintenance of SOP.

 

Conclusion

SOPs can sometimes feel intimidating or seem like they are putting up barriers to your work, but the hope is that having these SOPS available will create a culture of excellence in research. Providing guidelines and recommendations can lead to an increase in data quality, participant safety, and staff confidence and satisfaction. Ultimately, we will be better by having SOPs available. SOPs will benefit participants, study teams, sponsors, and the institution--it’s a win-win-win-win!

If you have any questions, please don’t hesitate to reach out to the BMC Clinical Research Network (CRN). Further information on the history and planned implementation of these SOPs can be found within the November 2022 CRRO Seminar presentation.

Stay tuned to “SOP Spotlight” here in the CR TIMES! We’ll cover a new SOP each month and provide some additional information along the way. In the next edition, we’ll be reviewing the “Institutional Clinical Research Policies and Guidance Library”.