Compliance Requirements for an eClinical Supply Chain Management Platform

This blog is the fourth in a series examining the requirements for an eClinical Supply Chain Management (eCSCM) platform. There are four categories of requirements for optimizing a clinical supply chain: 

1. Collaboration Requirements
2. Real-Time Visibility Requirements
3. Traceable Chain of Custody Requirements
4. Compliance Requirements

This blog will discuss the compliance requirements for an eClinical Supply Chain Management platform.

Protocols are becoming increasingly complex, and many require multiple amendments, making protocol adherence more challenging for clinical trials. In addition, federal regulations and best-practice guidance are constantly being updated. Without automated support for communicating, coordinating, and controlling collaborator processes, sponsors cannot ensure that research sites and other collaborators are adhering to the protocol. This also applies to regulatory requirements and good clinical practice (GCP) guidance. As a result, required safety checks might be missed, biological samples might not be collected, handled, shipped, or processed according to the protocol, and regulatory requirements and guidance might not be followed. This can cause subjects to drop out due to negative experiences, or the elimination of subjects due to protocol deviations, which can risk the clinical trial’s overall success. 

Today’s practice of research site staff referring to physical protocol manuals allows for misinterpretations, mistakes, workflow inefficiencies, and process delays. Manually rolling out protocol amendments can cause further confusion, inefficiencies, protocol deviations, and compliance violations. The compliance requirements for an eClinical Supply Chain Management platform detailed below are designed to address and alleviate these problems.

An online platform must be configurable to the protocol and its amendments while providing protocol-based workflows specific to each collaborator—sponsors, contract research organizations (CROs), research sites, suppliers, and labs—encouraging protocol adherence and regulatory compliance. 

Compliance Requirements

Most early-stage clinical trials aim to determine the safety and efficacy of investigational product (IP). It is essential to a clinical trial’s exculpatory outcome that sponsors can reliably prove collaborators have adhered to the protocol, and complied with best-practice guidance and regulations. Therefore, an online platform must strengthen adherence and compliance and provide defensible records that the protocol and appropriate regulations were followed. 

The compliance requirements for an eClinical Supply Chain Management platform are that it must:

• Be Configurable to Each Study Protocol
• Support Protocol-based Workflows
• Harmonize Activities Across Amendments
• Provide Role-Specific Privileges
• Support Regulatory Compliance and Best-practice Guidance
• Create Materials to Support Audits
• Provide Training and Education

Configurable to Each Study Protocol

Protocol deviations can result from research sites' misinterpreting complicated protocol manuals. Consistently referencing physical protocol manuals can be difficult for busy research site coordinators and clinicians. Though they might neglect or miss important protocol aspects if they do not. To prevent this, an online platform must be able to:

• Implement processes and procedures as defined in a research study protocol’s lab, pharmacy, and operations manuals
• Incorporate amendments as they come available and integrate the resulting changes in procedures

When these compliance requirements for an eClinical Supply Chain Management platform are met, it creates a single workspace that clearly defines what the protocol and any amendments require, reducing the possibility of protocol deviation. 

Support for Protocol-based Workflows

Protocols cover a variety of different practices—from which lab kit components to use for a procedure, recording IP dispensation, how to collect, register, process, ship, and store biological samples. Referencing the protocol documents can be labor-intensive, and without assistance, collaborators may miss or misinterpret an important protocol guideline, leading to deviation. An online platform must provide guided workflows that cover:

• Correct lab kit components to use for each procedure timepoint
• Recording when IP has been given to a subject
• How to collect biological samples and which type of biological sample is to be taken at each timepoint
• Registering and shipping each biological sample
• How each biospecimen is to be stored to maintain its validity and usability

Through this guidance, collaborators are able to perform their tasks with effective protocol adherence in an efficient manner. Configuring an online system to the protocols creates automated guardrails, so collaborators are less likely to miss or neglect the protocol.

Harmonize Activities Across Amendments

Incorporating amendments brings additional challenges. Research site staff may not always know which amendment their site is on, and—in the case of multiple amendments—how they affect each other. Since amendments are rarely rolled out to all research sites simultaneously, confusion and subsequent misalignment can occur for the sites, sponsors, and CROs. An online platform must be able to maintain:

• Multiple live amendments to the protocol, simultaneously
• Different amendments active at different sites

Through this ability, one of the essential compliance requirements for an eClinical Supply Chain Management platform, launching one or more amendments is simplified. The burden on sponsors is lessened because an online platform’s guided workflows are configured for each site based on the amendment they are on. As a result, onboarding research sites to incorporate amendments is eased, and adherence is increased.

Provide Role-Specific Privileges

Every collaborator in a clinical trial—sponsors, CROs, sites, suppliers, labs, couriers—has a unique role, and some collaborators have roles on multiple levels. If collaborators are granted access to data outside of their platform-assigned role, confusion and data compliance issues may occur. Access must be controlled to those trained to specific roles to assure protocol adherence, regulatory compliance, and data integrity. An online platform must provide users different levels of access according to their role and hierarchical responsibility:

• Clinical operations teams must have the option to manage the protocol and amendments and modify inventory plans, including SKUs, suppliers, and requisitions.
• Research site staff must be able to manage inventories, samples, and subject visits, with different permissions based on their role.
• Lab coordinators must be able to see all the biological samples and shipments that need to be processed.
• Who has visibility into what data.

With these privileges properly defined in the eClinical Supply Chain Management platform, collaborators are provided permissions according to their role. These role-based privileges further encourage protocol adherence and regulatory and guidance compliance

Support Regulatory Compliance and Best-practice Guidance

The Food and Drug Administration (FDA) provides regulations that, among other things, include best-practice for record-keeping and guidance for good clinical practice (GCP). If there is no consistent way to keep a record of activities, it can be challenging to prove compliance. An online platform must support and provide attestation documentation for:

• Title 21 CFR Part 11 electronic record creation, modification, and transmission to ensure authenticity, integrity, and, when appropriate, confidentiality
• ICH Good Clinical Practice (GCP) record-keeping to maintain a trusted, single source of truth for activities at the research sites 
• Attributable, Legible, Contemporaneous, Original, Accurate, and Complete (ALCOAC) compliant electronic records of IP, biological sample, supply, and activities during the trial with timestamps and attribution 
• Sunshine Act compliant proof and confirmation of supply and equipment reclamation
• 21st Century Cures Act data transparency for the patient from the site

An eClinical Supply Chain Management platform’s support for these regulatory and best-practice requirements is paramount for clinical trial collaborators to comply with regulations and guidance while creating documentation that attests to their compliance.

Audit Support Materials

Maintaining reconciliable records is essential to a clinical trial’s ability to pass an audit successfully. It can be challenging if records are kept on paper, emails, and spreadsheets and must be compiled and integrated manually. These manual processes make it difficult for collaborators to provide proper documentation for all actions taken and that accounts for all clinical supplies and biological samples to prove their compliance for audits. To avoid this, an online platform must be able to:

• Track actions taken by each user with a timestamp indicating when the action was performed
• Track who logs any activity related to biological specimens, and when and where it was logged
• Track who has had possession of IP, clinical supplies, and biological samples, and when and where they were
• Track subject visits and sample collection procedures at each timepoint during the study
• Provide an audit trail report template for creating auditor reports

The data collected by an online platform must verify to auditors that each subject’s participation, every action taken by collaborators, and all activity related to each clinical supply and biological sample were in accordance with the protocol and regulations. This data must also make complete reconciliation easy. Providing materials that make the auditing process more efficient and productive is one of the essential compliance requirements for an eClinical Supply Chain Management platform.

Training and Education

As discussed, protocols are becoming increasingly complex. This makes training collaborators on each protocol cumbersome for clinical research sponsors. Amendments, varied research site staff hours, and turnover can complicate this further. In contrast, training teams on how to use an online system that has documentation, online help, on-demand chat assistance, and the protocol embedded in its guided workflows is easier and more effective. The last set of compliance requirements for an eClinical Supply Chain Management platform, is the platform and its vendor must provide:

• Sponsor, research site, and lab staff training on the use of the online platform specifically for each research study
• An app-like interface with live online support and personalized response to every support request
• A comprehensive help center with articles and videos for productive self-service training

This set of compliance requirements for an eClinical Supply Chain Management platform removes the burden of training collaborators on the protocol manuals from the sponsor and addresses the related challenges.

Optimizing Clinical Supply Chain Management 

Optimizing clinical supply chain management is the overall value of an eClinical Supply Chain Management platform. Read our previous blogs to find out more:

• Who Needs Clinical Supply Chain Management Optimization
• When You Need to Optimize Your Clinical Supply Chain Management
• Four Reasons to Optimize Your Clinical Supply Chain Management
• Collaboration Requirements for an eClinical Supply Chain Management Platform
• Real-time Visibility Requirements for an eClinical Supply Chain Management Platform
• Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform

Or unlock our Clinical Supply Chain Management Toolkit.

Stay tuned for our next blog, “How to Implement an eClincial Supply Chain Management Platform.”

The Slope eClinical Supply Chain Platform 

The Slope eClinical Supply Chain Management platform was designed and developed to meet the above compliance requirements. These required capabilities include configuring an online platform to the specific study protocol, workflows based on the protocol, harmonizing activities across research sites according to amendments, providing privileges specific to the collaborator’s role, tracking materials to support audits, and providing training and education on best practices.

To see a live demonstration, contact us to talk to one of our clinical trial solutions experts.