Click on the question category or scroll down to see answers to frequently asked questions.
The Complion Platform:
Research sites of all sizes, across various therapeutic areas are currently using the Complion platform. Any FDA-regulated research site that needs to keep documents would benefit from implementing the Complion platform.
Because the Complion platform has been built by certified clinical research professionals, you will find that all of the documentation and workflow processes you currently perform can be performed on the platform. The difference is that we have engineered the Complion platform to be highly efficient in the way documents are collected, signed, and managed. An example of processes that can be performed include: study startup, processing amendments, managing correspondence, study closeout, safety reporting, facilitating monitor/audit visits, completion of Delegation of Authority (DOA), staff training, tracking file expirations, storing patient records and documenting deviations and violations. Advanced functionality at larger research organizations includes: FDA eSubmissions, FDA reporting, quality assurance, and coordination of multi-center trials.
How much staff effort is required to transition to electronic records and signatures in clinical research?
The Complion platform can be implemented for all new trials at research sites in as fast as two weeks, and at larger research organizations, in two to three months. It is suggested that clients identify a project manager to facilitate implementation as well as ongoing support, training and validation tasks. In our experience, this person can continue normal job functions without a significant incremental burden.
How can sites obtain reimbursement from sponsors for electronic records and signatures in clinical research?
Sponsors are reimbursing the per trial cost to research sites as a separate line item and/or as part of existing startup or archiving fees in a similar manner as for other electronic systems. The Complion platform can completely replace existing long term archiving costs and also provide significant financial return to the sponsor by enabling remote monitoring access or more efficient onsite monitoring practices. Please Contact Us if you would like to learn more, and our research-certified experts can help you explore how you too can obtain reimbursement following best practices.
The research site owns all information on the Complion platform. The information can be easily exported at any time for no additional cost, to an audit-ready PDF of the entire electronic binder or of specific components formatted with cover sheets, bookmarks, hyperlinks, page numbers and table of contents.
Yes. Research sites are solely responsible for the creation and maintenance of clinical research documents and records. In accordance with ICH GCP guidance and FDA regulations, sponsors and CRO’s cannot “require” or mandate how the regulatory process is managed at the research site level.
Yes. Complion works directly with sponsors and CROs to provide access to all of your sites. Complion can provide sites live or recorded training and validation teleconferences in less than thirty minutes as a part of your SIV, site training process and/or upon first login to the system. This video training process can also be accessible and managed in your existing site training portals or solutions. Sites and affiliated users can easily be entered and managed on the platform. The same level of support and customer community content and training can be provided to site, sponsor and CRO users.
Typically, our clients will utilize the Complion platform for all new trials starting after a given go-live date. Conversion of existing and/or archived trials typically requires a significant amount of scanning, file indexing and uploading into the platform. We can provide tools to help you facilitate this process and/or services to convert the trials for you.
The Complion platform has been developed based on best practices in collaboration with leading research sites for the specific intended use of creating and maintaining documents and workflows. The Complion team consists of research certified experts as well as software developers with expertise in document and workflow management systems. Because of this experience and focus, the Complion platform does what a CTMS cannot do – create and maintain audit-ready, Part 11 complaint electronic records and signatures with comprehensive and easy-to-use features on any device. The Complion platform augments and is compatible with existing systems that manage institutional review boards (IRB), trial databases, patient registries, billing, coverage analysis, Electronic Data Capture (EDC), biospecimens and/or staff tracking.
While shared drives are readily available and may even be regularly backed up by your research site’s IT team, they lack key software features required by the FDA in an entirely electronic document system, including: safeguards for deletion/misconduct, eSignature capabilities, audit trails, user access controls, encryption, reports and more. Furthermore, a research site that develops these features in their shared drive is then also required to perform user validation, training, software development and server management following documented policies. Complion offers all of the above.
Shared drives are not Part 11 compliant and therefore require the research site to maintain redundant paper binders in order to be compliant. The FDA has and is continuing to issue inspection observations to research sites for using shared drives. Learn more about Part 11 compliance and Complion’s solution.
In accordance with ICH GCP, Complion’s platform allows the research site to own and control documents and records from startup through long-term archiving, which are separate from the sponsor’s own records. The Complion platform was built by clinical researchers, for clinical researchers, for the specific intended use of managing electronic documents and records in 100% compliance with all applicable rules and regulations.
There are specific FDA requirements for research sites that maintain electronic records and signatures. Therefore, using a sponsor-provided portal or electronic Investigator Site Files (eISF) is not compliant and will require your site to keep redundant paper binders. The FDA has and is continuing to issue inspection observations to research sites not in Part 11 compliance. Learn more about Part 11 compliance.
- The Complion platform serves as the research site’s record as compared to the sponsor’s. Furthermore, it is compatible with sponsor-provided portals and therefore augments their capabilities.
- Typically, research sites on the Complion platform will receive various documents from the sponsor via the portal and then drag-and-drop those files into the Complion platform. Should the sponsor need to access their documents, the research site can provide access for the specific trial(s) and/or export an audit-ready PDF for upload into the sponsor portal. The PDF can contain the entire electronic binder or specific components formatted with cover sheets, bookmarks, hyperlinks, page numbers and table of contents.
Support, Education and Webinars:
Our Customer Success team includes research certified professionals who support you every step of the way, from implementing our software to fit your current processes, to ensuring that it meets your needs over the long term. We provide support both for your internal users as well as for all of your monitors and collaborators, including: customized training materials and work instructions; training and software re-validation for all new software updates; searchable online help center with videos and articles; integrated video training module; and unlimited live chat, email and phone support during normal eastern standard business hours.
How does Complion facilitate a community that shares best practices, addresses challenges and supports one another?
Inspired by our experience in clinical research, we understand that software alone does not solve all problems, but rather also requires the sharing of new best practices. Complion customers not only have access to our experts and resources, but also the combined knowledge of our customer community. Access to this exclusive community includes: regular Complion-facilitated community forums on various topics; on-demand training courses for self-reporting of continuing education credits; a library of template files, standards and processes developed by leading research organizations; and one-on-one time with Complion research certified experts.
It’s simple, just register and attend the live session. Then Complion will email the slides and a certificate of attendance to you for self-reporting of continuing education credits with your association.
Please email firstname.lastname@example.org and make a request to share your experiences, best practices and resources with the community. We look forward to hearing from you!
No. You can register up until the last second before the live webinar, however it’s a good idea to register early to guarantee your spot since space is limited.
It’s FREE …seriously. Even if you’re not a customer, we want to help by fostering a community that shares best practices, addresses challenges and supports one another. That’s why we have a robust library of resources and educational webinars to help your site achieve success. See our Resource Library.
The only item that will need to be downloaded will be the Outlook email integration. The great news is that this download only takes 30 seconds!
The Complion platform supports and is validated in most all active versions of major browsers across all major devices including: Internet Explorer (IE), Chrome, Firefox and Safari. We suggest newer versions of Chrome or Firefox for optimal use.
Yes. The Complion platform can be accessed on most major phones, tablets and other devices through your web browser without installing a separate app.
No. You can access the platform from any device with a connection to the internet.
Yes. There is no need to remember a new password as Complion enables single sign-on integration with many other commercially available and internal IT systems, including: LDAP, SAML and ADFS. Once the connection is established with your chosen system, you can right-click on trial identifiers and open related documents from the Complion platform with a single click.
The Complion platform streamlines the flow of information, reduces redundancy and protects an organization’s investment in existing systems through integration. As mentioned above, Complion enables single sign-on integrations with many other commercially available and internal IT systems, including: LDAP, SAML and ADFS. The platform also provides pre-built integrations with many systems, including: Outlook, FDA eSubmission Gateway and more. The Complion platform is standards-based with Application Programming Interfaces (APIs) that are designed to connect more easily with other systems, such as electronic Institutional Review Board (eIRB), Clinical Trial Management Systems (CTMS) and Electronic Medical Records (EMR).
We typically release new updates of software that require re-validation three to four times a year. The validation process is described elsewhere on this page. For every software update, the entire comprehensive re-validation process can be performed in a single meeting for every research site. This re-validation process may typically take thirty minutes for each new release, however we can take more time to meet your needs or expedite the process to fit your time constraints. Typically, for research sites deciding to perform this process on their own, this would require months of time and tremendous technical experience. Research sites are not required to validate or re-validate the platform on a per trial basis, but rather once at a platform level for all trials.
- Complion meets industry best practices for technical controls and security following documented and audited SOPs. All documents can be digitally archived indefinitely or following your research site’s record retention policy. There are minute-by-minute backups every single day, so if one of our data centers ever went down, your data would be transferred to another one within one minute and the most information that you could ever lose would be one minute’s worth of work. Additionally, there are full backups performed daily at geographically distinct data centers.
- Our data centers are compliant with FDA regulations. Please Contact Us if you would like to learn more about how we comply with FDA regulations.
- Although we have never had to use them to date, we do have documented disaster recovery processes that are regularly audited to ensure security and fast retrieval of your information.
- The research site owns all information on the Complion platform, which they can easily export from the system at any time, for no additional cost to an audit-ready PDF. We will keep your important information highly confidential and hold our employees to the highest ethical standards through documented training to ensure that we only access your information for support purposes. We maintain our own SOPs for hosting, software development and validation, and HIPAA security and privacy, including: software development, software developer validation, disaster recovery, backups, Complion staff training, cloud server installation, cloud server validation and internal audits. We are also regularly audited by a third-party FDA compliance specialist and can provide you with our latest compliance certificate.
Your information and the Complion platform can be hosted locally on your servers or in the cloud. However, we do highly suggest utilizing our cloud hosting service as it is in full compliance with the applicable regulations, including HIPAA and Part 11, and there is a significant burden and technical expertise associated with onsite installation and maintenance of a Part 11 compliant system. This burden includes maintaining and keeping documented records of the following processes: software development, software developer validation, disaster recovery, backups, server installation, server validation and regular audits. Furthermore, onsite installation of the platform may limit some of the ability to share files across external monitors and collaborators as well as impact performance times. When using our cloud hosting service, all integration options to onsite systems are still compatible and we can facilitate the regular backups of all of your data onsite. In addition, if there are concerns with storage of sensitive information in the cloud, we can facilitate the onsite installation of all files locally on your server behind your firewall, which is accessible by our cloud platform, however additional details may apply.
Complion follows a trusted 21 CFR Part 11 validation process developed in collaboration with leading research sites to ensure compliance following industry best practices. Complion works with our clients to separately validate the platform prior to implementation and with any new software updates, and can complete this process in a single meeting with staff at the research site who have no formal technical knowledge of Part 11. First, Complion will provide an educational overview on Part 11 as well as industry best practices for validation. Next, Complion will review the required processes that we manage for you in our documented SOPs. We will provide a certificate of compliance from our last regular third-party audit, but you are welcome to conduct your own audit too. Third, we provide a validation protocol that defines Part 11 requirements, platform design specifications and end user test cases. We can also customize such documentation for you to support an existing IT validation process. Finally, we facilitate platform testing following the validation protocol and produce a validation record. This entire process can be performed in a single meeting for every research site prior to implementation and with every software update. This process may typically take one hour prior to implementation and thirty minutes with each new release, however we can take more time to meet your needs or expedite the process to fit your time constraints. Typically, for research sites deciding to perform this process on their own, this would require months of time and tremendous technical experience. Research sites are not required to validate or re-validate the platform on a per trial basis, but rather once at a platform level for all trials.
Regulations and Compliance:
What are the applicable regulations, standards, guidance and rules for electronic records and signatures in clinical research?
- Sites must be familiar with the FDA regulation 21 CFR Part 11, ICH GCP, as well as any applicable FDA guidance documents.
- In March of 1997, the FDA issued rule 21 CFR Part 11 that provides criteria for acceptance by the FDA of electronic records and electronic signatures as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health. Read the FDA regulations.. Read more about Part 11 compliance.
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines on Good Clinical Practice (GCP) that are seen as the standard throughout the clinical research industry. Sections 4.9 “Investigator Records and Reports” and 8 “Essential Documents for the Conduct of a Clinical Trial” provide an overview of the document requirements for the research site, which are separate from those of the sponsor. According to these guidelines, research sites are solely responsible for the creation and maintenance of documents.
What are research sites required to do to use electronic records and signatures in clinical research?
According to FDA regulations, research sites are required to perform user validation and training on any electronic systems, prior to implementation and with any new software updates. Research sites should not use a validation letter, a certificate from the vendor or sponsor, or practice “validation through use.” The system must be validated for the specific intended use of maintaining electronic records and signatures, and validation must follow an established protocol and result in a documented validation record. There are additional requirements and documented processes required for research sites developing their own software and/or hosting software on their internal servers, including: software development, software developer validation, disaster recovery, backups, server installation, server validation and regular audits. Research sites are not required to validate or re-validate the platform on a per trial basis, but rather once at a platform level for all trials. Learn more about how Complion makes the validation process easy.
FDA auditors have given great reviews of the Complion platform since our platform is very user-friendly, helps foster compliance and provides multiple audit-ready formats for directed and comprehensive review. In fact, the FDA has been at the forefront of developing regulations and clarity since 1997 intended to permit the widest possible use of electronic technology compatible with the FDA’s responsibility to protect the public.
The really great news is that all signatures can be obtained with electronic signatures on the Complion platform. Sponsors and CRO’s cannot “require” or mandate how the regulatory process is managed because per ICH GCP sections 4.9 and 8, research sites are solely responsible for determining how to create and maintain documents. Such documents may be created and maintained entirely electronically as long as they follow the FDA’s 21 CFR Part 11 requirements. Using the Complion platform, a wet-ink signature page can be scanned following a certified copy process to enable the destruction or return of the original signature page to the sponsor. The research certified professionals on the Complion Customer Success Team work with our customers to best discover and implement the best processes for you.
Our platform is 100% compliant with all FDA regulations. Our clients have been audited by the FDA without any known inspection observations or 483’s. FDA auditors may access the platform in one of the following ways: (1) a special read-only auditor view, (2) “over the shoulder” of research site staff, and/or (3) by accessing in a single-click an exported, audit-ready PDF of the entire electronic binder or of specific components with cover sheets, bookmarks, hyperlinks, page numbers and table of contents.
What can happen to research sites that do not follow best practices for compliance in electronic records and signatures in clinical research?
The FDA has and is continuing to issue inspection observations to research sites.
Yes. The Complion platform meets all HIPAA security and privacy requirements. There are three ways that clients can utilize the platform in regards to PHI. First, some clients may choose not to store any PHI on the platform, in which case there are visual warnings on information entry, disclosures during training and documented processes to destructively remove any inappropriately uploaded PHI. Second, clients can store PHI on the platform following the appropriate IT review and legal processes at your research site. Third, we can also facilitate the onsite installation of the information and/or the platform itself, which does require additional requirements and documented processes, including: disaster recovery, backups, server installation, server validation and regular audits.
Working with Sponsors and Monitors:
Sponsors are in favor of working with research sites on the Complion platform because it fosters efficiencies and audit-readiness by enabling remote monitoring access or more efficient onsite monitoring practices with real-time remote access to the source versions of documents. In fact, most sponsors currently have active users on the Complion platform that with a single password can access designated trials across all of their sites with integrated training and support.
Do I need to ask permission from my sponsor to use electronic records and signatures in clinical research as a research site?
No. According to ICH GCP, research sites are solely responsible for the creation and maintenance of documents. They can maintain all documentation entirely electronically as long as they follow FDA rule 21 CFR Part 11 requirements.
Monitors have given the Complion platform excellent reviews. Since our platform is very efficient and user friendly, monitors are spending less time at each site while ensuring the highest standards of compliance. In addition, they no longer have to flip through the cumbersome paper based binders. In fact, most CROs and sponsors currently have active users on the Complion platform that with a single password can access designated trials across all of their sites with integrated training and support.
The research site identifies admin users who can control per-trial, role-based access to the Complion platform. When added to a trial, monitors new to the platform will receive an email in their existing email account with a link to register on the platform. Monitors that are already registered on the platform will simply receive an email notification and can access the new trial(s) on their next login utilizing their existing password for all research sites. Monitors have view-only access on the platform, but do have access to various search, export and communication tools to foster efficiency and compliance for both the research site and monitor. Additionally, monitors have access to all support and customer community content and training. Monitor access can be provided throughout the lifetime of the trial to greatly reduce the amount of correspondence with self-service access, or can be provided for a pre-defined period of time. In both cases, admin users can remove monitors from specific or all trials at your research site at any time.
No. Monitors register once on the platform and can access designated trials across all of their sites with integrated training and support. In fact, most sponsors and CROs currently have active monitors on the Complion platform.