of 39 A Data record must only exist on a single line.

 A field delimiter is configurable within the application. Most common delimiters are pipe "|" and comma "," with optional quotes for values that contain comma within text.

 Empty fields in a record must be designated by two consecutive delimiters.  Every record must contain the same number of fields.

 Each Data record in the Data file must contain fields that constitute a key to uniquely identify each record.

 Data file may be cumulative (All unchanged, changed and new records must exist in the Data file to be uploaded.)

 Data file may be incremental (The incoming file will contain records that were created, changed, or deleted between the last and current Data transfers. Records that were not included in the incremental transfer are assumed to be unchanged by the application.)

 The application supports transaction type flags with each Data record signifying Insert, Update, Delete, and Retransmit transactions. This will allow support for incremental CDISC transfers where transaction flags are:

o "I" for Insert o "U" for Update o "M" for Delete o "R" for Retransmit

 When a transaction specified by a transaction type flag cannot be performed then an error will be generated.

 The application optionally can process Insert and Delete transactions sent in the same Data file.  Data types supported are: Text, Integer, Float, and Date

File Naming Conventions

Data files sent by the Data file supplier to Oracle must adhere to specific file naming conventions in order to satisfy the requirements for uniqueness and the target destination for processing.

 The Data file name must be ASCII case insensitive.

 A file name must contain the EDT name separated from the other file name components by an underscore.

 Enforcing the existence of the Trial name within the file name can be optionally selected by setting an appropriate configuration setting.

Data Transfer Procedure

All Data transfer procedures documented here conform to the Oracle Cloud for Industry (OCI) Secure Data Transmission Standard. Changes to the OCI Secure Data Transmission Standard supersede any Data transfer mechanisms described in this document.

The Data file supplier must transmit the Data files across a secure SFTP channel to the specified Oracle sFTP server. Data will be sent to a Trial specific folder on the Oracle sFTP server. The folder structure will adhere to the Oracle standard.

The DDL Windows Service on the machine that hosts the InForm Trial will monitor this folder on the Oracle sFTP server for any new Data files. Once a file has completed uploading it will be copied from the Oracle sFTP server, processed and loaded into the appropriate Trial specific DDL Data repository. The

compressed version of the original Data file will be archived in persistent Data storage, and viewable on the DDL Log Viewer page within the InForm portal.

Secure FTP (sFTP) Access

All Ddata file access must be done using sFTP in accordance with the Oracle Cloud for Industry (OCI) Secure Data Transmission Standard. Changes to the OCI Secure Data Transmission Standard supersede any file access mechanisms described in this document.

Each instance will be associated with a secure FTP location unique to each Vendor or Data file type for the delivery of Ddata files to be imported by DDL

Data file suppliers must have a supported sFTP client to login to Oracles’ hosted sFTP server at sftp.webcrf.net and transmit files. Oracle currently supports the following sFTP clients:

 SecureFX from Vandyke Software (preferred client)  WS_FTP Pro Version 9 from IPSwitch

 Putty Command line client  Win SCP

All Data file suppliers will be granted named user accounts with access privileges to the appropriate Trial DDL folders. Accounts will be created according to Oracle’s SFTP Service Policy.

Data supplier user accounts can access multiple Trial folders. If a data supplier account is associated with more than one Trial folder, then the Data supplier’s transfer process will be required to navigate to the appropriate folder after login. This navigation can be done through use of the appropriate commands depending upon the sFTP client.

Error Handling Oracle SFTP Server

SFTP provides authentication, Data compression and file integrity algorithms to help confirm that the file received is the same as the file that was sent. If there is a connectivity issue to the Oracle sFTP server (either from the Data supplier or from the InForm server), then Oracle Customer Support may assist with resolution.

DDL Import

For the import of Data into DDL data repositories in the reporting database, audit logs will be generated for every import indicating success or failure. The audit log along with the copy of the Data file will be stored in persistent Data storage, and viewable on the DDL Log Viewer page within the InForm portal. The application can be configured to send email notifications for success and error.

Deliverables and Customer Dependencies

The deliverables for a given project are dependent upon the components included in that project. Not all projects will produce all of the deliverables listed below. Some common deliverables that apply to most projects include:

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 Data Requirements – These are written by the Oracle project team to document Your specific Data file configuration needs for the DDL Integration. It will also include the necessary external Data type definitions necessary to accommodate the DDL Integration.

 Vendor Requirements – These are written by the Oracle project team to document the vendor specific configuration needs for the DDL Integration including user access and email notification options.

 Generate design specifications from Your-supplied requirements. One design iteration is included for the design specifications.

 Project Plan – This plan will be created and maintained by the Oracle Project Manager. It will detail the tasks, timelines, and milestones that Oracle and You are responsible for, as applicable.  Communication Plan – This document is created and maintained by the Oracle Project Manager.

It describes the team members, their responsibilities, and their contact information.  Configure DDL components as defined in the design specifications.

o Create Study eCRF configurations corresponding to the specified Data file(s). o Create external Data type specification files (EDTs) corresponding to the specified Data

file(s).

 Create secured FTP file directories according to the configuration specified in the Vendor specification requirements document.

 Testing –

o Perform smoke testing to validate the designs.

o Document the test cases needed for this configuration, and perform formal testing of the DDL Application.

o Conduct an independent validation of the DDL Application configuration by testing components against approved specifications.

 UAT (up to 1 round) –

o Install and configure the DDL Application in Your UAT environment. o One (1) User Acceptance Testing (UAT) findings meeting. o Respond to questions that You raise in UAT.

o If required, deploy a new configuration to the UAT environment for You to re-test. o If additional rounds of UAT are required, the Change Order process will be followed

(including additional fees and time).

 Once UAT is concluded, install and configure the DDL Application in Your Production instance.  Fixes to the Production DDL Application –

o Related documents are created by Oracle and approved by You.

o Update the UAT instance with a fresh extract of the Production instance and

configuration of DDL only if required, each time a Trial fix or Trial Change Order needs to be tested.

o Your use and Oracle’s maintenance of the UAT instance is limited to the implementation of fresh extracts when Trial fix or Trial Change Order related activities are required.  Archival Documentation – This is a package of documentation that was maintained by Oracle

during the course of the Trial. After the DDL application is decommissioned, this package is sent to You for archiving.

Your responsibilities for a given project are dependent upon the components included in the project. Examples include but are not limited to:

 You are responsible for managing the relationship and communication with the Data file supplier(s).

 You and Data file suppliers are responsible for correcting and resubmitting rejected records if records are rejected due to Trial or Data supplier oversights.

 Delivering clear and complete requirements in accordance with the agreed timeline planning. These may include form, Trial configuration, and database requirements. If final requirements are not available, You and Oracle may mutually agree to begin Trial design with draft requirements. This latter approach may be subject to additional fees.

 Providing input into the creation and maintenance of the project plan as requested by the Oracle Project Manager.

 Negotiating in good faith an estimated timetable for any revised or additional milestone dates that are introduced after the initial timeline agreement.

 Ensuring that all key stakeholders, decision-makers, and team members are present and/or involved with all key meetings and deliverables (i.e., planning and review of the DDL application specifications, UAT, etc.).

 Ensuring that all key stakeholders, decision-makers, and team members adhere to the agreed timelines.

 Ensuring specifications meet the regulatory requirements for the Trial.  Acceptance of design specifications in a timely manner.

 Acceptance of the configured DDL application for release to UAT and for release to go-live.  Testing the DDL application (UAT) to Your own standard operating procedures and/or work instructions and for creating and testing Your own test cases. This includes capturing UAT feedback that is clear, reproducible, and actionable in the Oracle-provided template. If changes introduced during UAT are required, the change management process will be followed (including additional fees and time).

 Ensuring that all users are trained prior to accessing the system. This includes maintaining all training records.

 Managing and overseeing third party vendors (i.e., lab vendors, Your external partners, etc.).  Reviewing and approving documents related to Production DDL application changes and fixes.  Database Extracts – These database extracts may be used by You to analyze and report on Your

Data captured by the configured DDL application. It is Your responsibility to request an export online and to download it to a secure location.

CRF Submit – Additional Runs