General Product Information

Q.1 Does Trial Interactive support PDF Portfolios?

Answer: Portfolio PDFs can only be handled by Adobe Acrobat, as they are a proprietary Adobe format and cannot be supported by other applications such as the TI Viewer or Google Chrome’s PDF Viewer. To view these PDFs, we recommend downloading them and opening directly in Adobe Reader.

Q.2 Does TI have the ability to take existing TMF folders and documents and drag them into TI?

Answer: Yes, TI supports the mass importation of existing documents.

Procedure:

1. Zip the folder structure and documents

2. Bulk upload with the option to unzip the file chosen

Also, this can be accomplished on the Chrome browser by dragging and dropping a root directory from the machine into the bulk upload window (this is not supported in other browsers).

Please note that this will not carry over metadata from other systems.

Q.3 Does Trial Interactive have a data processing agreement with Amazon Web Services, specifically for GDPR?

Answer: Trial Interactive leverages AWS for all data processing and storage. As such, TI falls under AWS’ data processing agreement for the purposes of GDPR.

Important

• This can be accessed on the Amazon website here: https://aws.amazon.com/blogs/security/aws-gdpr-data-processing-addendum/.
• The specific document may be accessed here: https://d1.awsstatic.com/legal/aws-gdpr/AWS_GDPR_DPA.pdf.
• The ISO 27001 certification may be accessed here: https://aws.amazon.com/compliance/iso-27001-faqs/

Q.4 Does Trial Interactive have a way to connect to other content management or document management systems?

Answer: Trial Interactive’s Content Connector is a generic connector that supports multiple content repositories, including Veeva, Documentum, Alfresco, CMIS, and others. Our TI Content Connector is useful for synchronizing your Regulatory, Quality, or Clinical content systems with TI for eTMF. It is a validated application that can be used to connect to a 3rd party system. Because some systems are competitors of ours, they may not certify our TI Content Connector, which is to be expected. However, we have validated it, and we will certify it as a part of any content integration we complete on behalf of our customers.

Q.5 What is the typical turnaround time for a client request for SOC1 and SOC2 reports? Also, will the vendor retain the ultimate responsibility to resolve any SOC1/SOC2 issues, or does the vendor expect to work directly with the hosting provider?

Answer: SOC documentation will be provided through a virtual Audit room or in-person only. The SOC3 summary is always available directly from the hosting provider or vendor. As vendor we take ultimate responsibility for all hosting issues. We are providing our software as a service with hosting as part of that service.

Q.6 Should an upgrade cause unexpected issues that do not impact all vendors or customers but do impact one client specifically due to a unique setup e.g. a business process/workflow, what is the typical resolution approach?

Answer: After every upgrade, for 2 weeks afterward we handle all incidents reported through our hyper-care channel, ensuring that we are responsively prioritizing issues. The priorities defined in our MSLA determine the service level targets in terms of time-frame, but we also define incident urgency based on Hyper-care status and other attributes, thus ensuring that upgrade issues are handled more efficiently. Finally, a technical project manager is normally assigned to handle the upgrade and stay on as a contact point for 2 weeks afterward.

Q.7 Does TI have a fully functional CTMS system that has been deployed at other client locations? If not, is there one in consideration and when will that be available for production release?

Answer: We are currently developing a CTMS system that is scheduled to be available in 2020. Any new customers who are interested may participate in our Customer Engagement Programs, specifically a focus group for the CTMS, to ensure we are getting appropriate feedback and involving interested parties in design reviews and functional prioritization of new products.

Q.8 Does the system have the ability to search document contents in addition to being able to search document names and associated metadata?

Answer: Yes. If OCR is enabled, the Search option can search document contents.

Q.9 Concerning the system’s machine e-learning abilities, what if someone repeatedly misidentifies a document resulting in incorrect training of the AI? How do we systematically un-train the AI on the faulty identification?

Answer: Once the document is corrected, the AI is 'untrained' automatically. Also, the AI is looking at multiple examples. If there are sufficient examples, a small number of misidentified documents would not have a significant impact on the model.

Q.10 What model of validation does Trial Interactive follow?

Answer: Trial Interactive follows GAMP 5 for all validation activities.

Q.11 How do I enable the Machine Translation Function in TI?

Answer: Optical Character Recognition (OCR) is specific to language and character set. OCR must be enabled by our Service Desk prior to utilizing the Machine Translation feature in a room so that the correct character sets are enabled in the room. Machine Translation is specific to language and API. Many times, the specific APIs must be enabled by the Service Desk.

Q.12 What’s the maximum size file allowed to be emailed to Trial Interactive?

Answer: The file attachments of up to 120MB are supported in emails sent to TI. One point of caution is that the sending email server will often have limitations set at < 100MB, most often 20 or 30 MB, which will prevent the file from being sent successfully. If this occurs, Trial Interactive Solution Engineers can work with your IT department to increase the email size limitations and support the full 120MB attachment size.

Q.13 What video formats are supported through Trial Interactive?

Answer: In Trial Interactive you can post videos and play them through the TI Viewer. The TI Viewer supports MP4, MOV, AVI, and similar formats.

Q.14 What technology does Trial Interactive use for its Collaborative Edit feature? Does it work just like MSOffice™ or Microsoft Office365™?

Answer: Several online editors allow the modification and editing of native Microsoft Office formats, specifically MS Word, MS PowerPoint, and MS Excel. While nothing that works as a thin-client, no-install editor will be quite as functional as the native Microsoft Application, several products come close, including OnlyOffice, OpenOffice, and MS Office Online / SharePoint. Trial Interactive uses OnlyOffice™ for our Collaborative Edit feature. OnlyOffice allows for the online collaboration of native MSWord®, MSPowerPoint®, and MSExcel® documents. OnlyOffice is continually improving their product, and has actually overtaken OpenOffice as the #1 non-native online MSOffice editor, comparing quite favorably to MS Office365.

Q.15 What is the largest file size that can be uploaded to TI, and how are large or specific file types handled?

Answer: The TI system supports multiple methods of file upload, each with specific size limits. The Bulk Upload feature allows files up to 2 GB, while files up to 120 MB can be submitted via email. For significantly larger files, up to 200 GB, users can upload via sFTP or physical drive, which TI can store and provide access to. Additionally, the team can upload files directly through the backend interface and can import it to the system.

Q.16 What file formats can be opened by the TI Viewer?

Answer: The following files can be opened in TI Viewer.

• PDF - all versions

• Images: JPEG, PNG, TIFF, GIF, BMP, JNG, PBM, PSD, EPS, PS, DCM (Format DICOM) and all formats supported by ImageMagick
• Microsoft Office Documents: Word (.doc, .docx) , PowerPoint (.ppt, .pptx), Excel (.xls, .xlsx), WordML (.xml), Visio (.vsd)
• Composite files: ZIP, EML, MSG
• Others: TXT, OpenDocument (LibreOffice or OpenOffice)

Q.17 How does TI handle XPT files?

Answer: XPT files can be seamlessly stored in Trial Interactive. However, XPT is an SAS proprietary file type and, for that reason, our internal viewer is unable to open those files. We recommend downloading SAS Viewer 7 to view all SAS filetypes.

Q.18 How does Trial Interactive Define a Major vs. Minor release?

Answer: Trial Interactive differentiates between a major and minor release in the following ways

• Major Releases: Major releases are defined as those that introduce a paradigm shift in the way Trial Interactive is used and/or functions. This can include (but is not limited to) redesigned UI, architectures, or the addition/modification of major functionality that may have an impact on data or content. Major Releases of the Trial Interactive system are subject to Full Regression testing. That is, all existing Test Cases will be carried out on Feature Complete builds of software. Major releases are supplied with pre-release notes no less than 6 weeks prior to upgrade and software deployment, along with a full impact assessment of each proposed functional change, and final release notes are supplied to customers at time of release. Finally, a minimum 4-week formal pre-release period is scheduled for major releases, providing customers time to review the updates prior to deployment.

• Minor Releases: A Minor release of Trial Interactive includes new features and enhancements. A minor release may also include the addition of new functionality that is transparent to the end user (e.g., may impact the administrator), defect resolutions, and additional modules. Additional modules are add-on functionality available to the customer that does not impact the core business case. Minor Releases of Trial Interactive are subject to targeted risk-based regression testing. All in-scope Test Cases are re-executed against Feature Complete software. The scope of final regression testing is determined by Software QA in conjunction an assessment of functional risk. Minor releases are supplied with pre-release notes no less than 4 weeks prior to upgrade and software deployment, along with a full impact assessment of each proposed functional change, and final release notes are supplied to customers at time of release. Finally, a minimum 2-week informal pre-release period is scheduled for minor releases, providing customers time to review the updates.

Q.19 What does SAR mean?

Answer: This means that a Strategic Alliance Room for all project related documentation, training materials, communication plans etc. is prior to the kick-off meeting supplied; this will be stored in the Amazon Cloud.

Q.20 How much in advance would you need to be made aware of an audit?

Answer: Activities that require physical participation or in-person attendance require a minimum of 21 days' notice. Remote audits, however, can be conducted on a shorter timeline.

Q.21 If another CROs uses another eTMF system, how would the transfer to the TransPerfect system work and what are the differences with regard to time, complexity, and effort during the migration process?

Answer: There are tools available to allow to build a structure in TI and a perform a straight input of content. There is also the capability available to upload an entire structure with content and with metadata. If the client has a standard set of metadata, it is easy for TransPerfect to apply the same mapping against that algorithm. Depending on the complexity the mapping can be very straight forward due to a team at TransPerfect being available with extensive experience.

Q.22 In case of an ongoing inspection and the system goes down, what kind of backup or issue resolution mechanism is available to ensure all-time accessibility of the system?

Answer: If there is an ongoing archive every service request / ticket is treated as priority 1. This is escalated to the top during an audit. With regard to disaster recovery there a couple of mechanisms in place: TransPerfect is in multiple availability zones (each availability zone being a completely separate infrastructure – a copy of the database is kept in secondary availability zone so that recovery can be performed within 5 minutes) and additionally TransPerfect has a disaster recovery site and there are related DR policies available and followed in such cases. During a formal agency inspection with advance notice to TransPerfect hypercare will be performed by TransPerfect during this window of time, the TransPerfect Service Desk is also made aware of the ongoing audit and all background activities (patches, etc.) is not done during inspections. TransPerfect has a recovery point of 30 minutes with 15 minutes incremental been taken and two full backups every week.

Q.23 What are the dimensions for logos added to the TI sign-in screen on dedicated instances?

Answer: Dimension: 88 x 72, Width: 88 Pixels, Height: 72 Pixels

Q.24 What is the document-type/icon relationships in TI?

Answer: Below is the list of available file types which have their corresponding icon. Anything other than these file types will default to being represented as a paper clip icon (.msg).

TYPE ICON

.gif , .jpeg , .jpg, .jpg, .png , .pdf, .doc, .docx

.xls . .xlsx , .csv, .aac, .aac, .mp3 , .ogg, .avi ,

.mkv , .mp4 , .webm , .m2ts , .gz , .zip , .css

.file, .txt, .dir , .msg , .flv , .ppt, .html

Q.25 Is TransPerfect registered with the EMA's Organization Management Service (OMS) database?

Answer: Yes

Table 1.

Organization ID	Location ID	Name	Organization Type	Address: Street Name	Town/City	Post Code	Country	Telephone Number	Email Address
ORG-100043494	LOC-100071938	TransPerfect	Industry	1250 Broadway – Floor 32	New York	NY10001	USA	+1 212 689 5555	mailto:info@trialinteractive.com

Organization ID	Location ID	Name	Organization Type	Address: Street Name	Town/City	Post Code	Country	Telephone Number	Email Address
ORG-100043494	LOC-100071938	TransPerfect	Industry	1250 Broadway – Floor 32	New York	NY10001	USA	+1 212 689 5555	mailto:info@trialinteractive.com

Q.26 Are all configurations, including any post-live changes, applied to the UAT instance first, or are updates made directly to the Production instance?

Answer: Yes. For the UAT, we synchronize the UAT with the latest approved configuration, which would include any production updates, assuming they are an approved part of the configuration. Once UAT passes, we then synchronize and upgrade production with the new configuration. In both these cases, we provide a configuration QC checklist with screenshot after the updates are made.

Q.27 Where can we perform installation and configuration tests for both pre-live and post-live configuration changes in UAT or Production instances?

Answer: All installation and configuration tests are conducted on the UAT instance. Once completed, the configuration is updated in the Production instance, followed by a quality check (QC) of the configuration. An optional UAT may be performed based on customer preference.

Q.28 Will IQ be performed on both the pre-prod and prod environment, considering that UAT will be conducted on the pre-prod environment?

Answer: The IQ would be performed on both the pre-prod and prod environment. Since UAT will be performed on the pre-prod environment, it is necessary to make sure it is installed and configured correctly and the same as the production environment.

Q.29 Does TI/TransPerfect perform IQ and OQ in the pre-prod environment and IQ in the production environment? Will the client perform the UAT in pre-prod and prod?

Answer: Yes. This is the standard method we follow. We conduct both an IQ as well as a PDC (Post Deployment Checklist) for verification, followed by the Configuration QC mentioned above

Q.30 Will the OQ that TI performs on the pre-prod environment include testing that has already been done on the base product, as well as any additional configuration changes needed for the client?

Answer: Yes. TI will perform OQ on the pre-prod environment, which will include testing already completed on the base product and any additional configuration changes required for the client.

Q.31 Will TI users have a single dedicated instance for both the UAT environment (pre-prod) and prod environment?

Answer: There will be a single dedicated instance for both our UAT environment (pre-prod) and our prod environment. TI would only make controlled changes to the production environment, i.e., changes that have been tested in the UAT instance.

Q.32 Are patch updates internally tested and rolled out in the production environment only?

Answer: For patch updates, we internally test and validate those and deploy them on behalf of customers. We would follow an RB timetable and project technical services team.

Q.33 How are the patch update changes controlled and communicated?

Answer: Configuration changes are accompanied by a formal sign-off process. Each change follows our established change management protocols and is communicated directly either through a service desk ticket, a support bulletin, or the designated Project Manager.

Q.34 Has Trial Interactive undergone an assessment and validation by an authorized organization to confirm compliance with any security standards and best practices?

Answer: Yes, Trial Interactive is certified by HITRUST CSF.

Q.35 What is the function of a watermark, and its significance?

Answer: Watermarks can be used to protect confidential information and to indicate the validity of a legal document. Its purpose is to make it more difficult for the original image to be copied or used without permission. Watermarking helps protect the copyright of the document and ensures that it cannot be reused or altered without permission. This means that the users can still preview the document without the risk of stealing/misusing it.

Q.36 What are the Pros and Cons of keeping or removing a watermark?

Answer: The following are the Pros and Cons of keeping or removing a watermark.

• Pros: It contributes to enhancing data security and maintaining confidentiality.

• Cons: Adding a watermark to the document may distract the viewer from the main subject.

Q.37 What is the character limit for the Comments fields in eTMF Metadata?

Answer: The eTMF supports up to 4,000 characters in metadata text fields, allowing for the inclusion of about four paragraphs of text.

Q.38 How are the calculations for the figures on the dashboard made?

Answer: Refer to the table below

Dashboard Name	Calculation Parameters	Availability (Rooms)	Clickable or Unclickable	View Modes
Countries	Number of countries in the room	eTMF Collaborate	Unclickable	Overview and Detailed View
Pending Sites	Number of inactive investigative sites	eTMF Study Start-Up	Unclickable	Overview and Detailed View
Active Sites	Number of active investigative sites	eTMF Study Start-Up	Unclickable	Overview and Detailed View
Total Documents	Overall number of documents in the room.	All rooms	Unclickable	Overview and Detailed View
Collected Documents	The number of collected documents. This number includes only ‘documents’ in all modules in a room, no deleted, purged, or missing documents.	eTMF Study Start-Up	Clickable	Detailed View
Missing Documents	The number of missing documents. This number includes all eTMF placeholders that have no document we can consider as collected. This is the difference between the number of requirements we have in a room and the number of requirements we have already collected. In the corresponding grid, we see all placeholders. We still have to submit a document and all submitted documents we do not consider as collected. For one placeholder, we may have several submitted documents and that makes a difference in the number of missing documents we have in the KPI dashboard and the grid.	eTMF Study Start-Up	Clickable	Detailed View
Required Coding	The number of non-final documents which are in a workflow.	eTMF Study Start-Up Note: It is available for eTMF or Study Start-Up rooms with the Workflow module enabled for Editors or higher-level users.	Clickable	Detailed View
Final Documents	The number of documents with final status.	eTMF Study Start-Up Note: Workflow module must be enabled.	Clickable	Detailed View
Expired Documents	The number of expired documents.	eTMF Study Start-Up Collaborate TI Docs	Clickable	Detailed View
Expiring Documents	The number of expiring documents. During the expiring period, we have configurable room-level settings. By ‘Expiration Dashboard View’ option, we set the number of days we consider the document as ‘Expiring’ before the expiration date.	eTMF Study Start-Up Collaborate TI Docs	Clickable	Detailed View
Open Queries	The number of Pending and InProgress queries.	All rooms with Query Resolution module enabled.	Clickable	Detailed View
eSignature requests	The number of documents that were sent to the eSignature workflow stage and were not signed yet.	Collaborate TI Docs	Clickable	Detailed View
eSignature in progress	The number of documents that were sent to the eSignature workflow stage and signing is in progress.	Collaborate TI Docs Note: The eSignature module must be enabled.	Clickable	Detailed View
Periodic Review	The number of documents that require periodic review.	Collaborate TI Docs Note: The eSignature module must be enabled for Editors and Higher-level users.	Clickable	Detailed View

Q.39 Can the documents be placed directly into the TMF index structure?

Answer: This is not a recommended practice. Regulatory authorities require a QC process to review and approve documents before they are added to the TMF structure. Trial Interactive supports this requirement through configurable workflows. Once the workflow is completed, the document can be automatically routed to a final published folder within the TMF structure.