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Integration map

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Impact Global

on 28 November 2018

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Transcript of Integration map

IMPACT
ACCORD
PLANIT
FinD
IMPACT is a global clinical trial management system (CTMS) integrated directly with ~30 other systems, utilities and databases (not all of them are included here).
Study Operational Data, which is mostly exported from IMPACT to other systems, triggers multiple downstream processes such as safety reporting, study registration on
clinicaltrials.gov
, budget calculation and others.

IMPACT can be divided into 4 basic modules:
Progress module
contains study, country, site and subject level information: timelines, recruitment, basic study design details and responsibilities.
Investigator module
contains information about facilities and clinical personnel participating in the studies.
MySites module
supports onsite and remote monitoring activities: tracks Informed Consent versions and protocol deviations, produces visit reports or follow up letters etc.
Reporting module
provides access to pre-defined system reports. There is also a link to BO reports, built on SAP platform: a tool which allows customization and/or ad-hoc report generation (data is refreshed on daily basis).

Clinical data is recorded in IMPACT according to the build-in structure:
Investigational Product > Clinical Development Plan > Study > Country > Site > Patient
This structure ensures that if one patient is recorded and FSI date is entered on site level, not only site, but also the whole country and the whole study reaches the FSI status.

PLANIT is a fundamental source of information about AZ current and planned projects and portfolio (internal and outsourced): their status, available resources, costs and timelines.
The PLANIT Process describes the project management steps that facilitate planning, approval and execution of the work within the R&D Operating Model.
PLANIT system components:
Planisware
shows the project lifecycle
MyTime
records actual working hours and shows available resources
Dashboard Reports in Spotfire
show project related graphs and charts
BO reports
are used to generate data containing tables

Studies created in PLANIT are automatically transferred to IMPACT after meeting specific requirements, 9 months prior to planned FSI.
Actual dates

Study level dates:
CSP approval
FSI
LSI
LSLV
DBL
Planned stats complete
CIM
CSR approved
Interim and Primary Analysis dates for DBL, PSC and CSR Approved if applicable

Planned dates
CDP Code
CDP Description
planned number of patients
actual number of patients
under treatment
on study & country level
Integration

map

v4.0, 07-Mar-2018
MySites
ACCORD is the
financial web-based application
used by R&D and Marketing Companies for their central cost reporting. It supports the monthly reporting process as well as the generation of forecasts.
To accurately forecast external and internal spend, ACCORD uses information transferred from IMPACT (recruitment plans, milestones) and data, which is directly input into ACCORD.
ACCORD allows for study search based on its financial units, shows partial and total number of subjects, and estimated study costs.
Reports are generated at the end of each month (usually around 28 of each month).
Financial reports and forecasts are transferred to OPAL and included in the general study characteristics.
eTMF
Veeva Vault eTMF is a claud based system for managing essential clinical trial documentation, which serves to demonstrate compliance of the investigator, sponsor and monitor with regulations, SOPs, and ICH GCP. Any of the documents retained in the eTMF is a subject to review during inspection.
eTMF enables global access to the Trial Master File (TMF) documents and faster retrieval of documents when required for submissions or inspection.
Data migration from IMPACT drives the creation of the study/ countires/ sites
The Master TMF Index contains a list of Artifacts (artifact = document type) that collectively represent the Trial Master File and includes descriptions of “purpose and definition” of all of them.
ESSROS
ESSROS (Externally Sponsored Scientific Research Operations System) also known as Vision Tracker, is a system for conducting and management Externally Sponsored Researches (ESR, alternative name ISS, Investigator Sponsored Studies) by a non-Company Researchers according to the applicable regulations and laws of the country involved.
ESRs are the studies using AZ drug but having sponsor different than AZ.
Firstly study is manually set up in IMPACT.
Then one way integration from ESSROS to IMPACT, based on study D-code, is switched on CSP approval entering in ESSROS.
Integration does not cover study cancellation. It has to be done manually in IMPACT.
1. Study Set - up:
Study Code must be available in IMPACT. Study Category field cannot contain any of the following three values: Externally Sponsored Research (ISS), Externally sponsored – other company (EXT), Only entered for costs on ACCORD (COST).
2. Country Set - up:
at least one Site must be created and confirmed in IMPACT to trigger the IMPACT-Veeva Vault eTMF Integration.
3. Site Set - up:
all following information must be added to site in IMPACT :
Study Site Number for AZ studies and Site Reference for MED/MAZ studies (MED-MedImmune; MAZ-MedImmune-AstraZeneca).
Study Country name,
Primary Facility – Site Location
Site must have "Confirmed" status
3a. Below information is strongly recommended to be added to Site in IMPACT:
Principal Investigator name in Study Site Parameters -> Study Site Properties or/and Personnel -> Clinical Personnel
Primary Monitor
4. The study information (Study/ Country/ Site) from IMPACT is transferred to eTMF once a new study is set up in Veeva Vault eTMF
ClinStore
ClinStore is a clinical document management system that captures, stores and assembles CRF documents for submission received from internal and external sources
ClinStore will be substituted with Veeva Vault system

Responsibilities for loading the documents into ClinStore are:
in case of internal studies: the Cognizant DMC team
all other studies: Enablement in Poland Hub
Besides CRFs ClinStore can also store other documents such as: paper CRFs, ePRO, laboratory reports and adjudication data.
Special technical requirements regarding CRFs files (pdf) and delivery requirements concerning folder structure are listed in ClinStore Input Specification document and Submission Ready Standards (SRS).
Cognizant DMC team is responsible for the complete CRF publishing process for all internal studies. Regulatory Documentation Managers team (RDMs) is responsible for exporting files stored in ClinStore (internal model) or for approval, publishing the casebook and exporting the files (outsourced model) when required for a submission.
IDP level
CDP Code
CDP level
Study Code
PharmaCM
PharmaCM is used to manage internal and external data sharing requests and to register clinical studies on
ClinicalTrials.gov
and
EudraCT
websites.
The process of clinical study registration on ClinicalTrials.gov must start at least 30 days prior to First Subject In (FSI) date. Results must be entered into PharmaCM at least 45-60 working days prior to the submission due dates.The study must be registered, i.e NCT number must be obtained, prior to FSI date.
Study information (29 fields) is automatically uploaded into PharmaCM based on IMPACT data. Integration is triggered as soon as the study is set up in IMPACT.
Three required forms go trough the workflow process including edit, review, approve and submit of:
Results Registration Form
Clinical Trial Application Form
Protocol Registration Form
Adding the "Site ready to enroll" or "FSI" actual dates in IMPACT
changes site status to recruiting on ClinicalTrial.gov website.
Study level
Study Code, Study description
Study parameters: Study Phase, IND Study, Entered Treatment/Randomised Planned & Actual
Responsibilities: Responsible for Posting (AZ, Medi, Pearl)
Study Design Details: Design, Randomisation, Healthy Volunteer Study
Subject Design: age & gender
Site level
primary facility: number, name, address, purpose, tel & fax and department details
site status
Data transfer:
once daily
RAVE
RAVE is the main data capture system used at clinical study sites to record clinical information on electronic Case Report Forms (eCRFs) as the subject attends for visits. It gathers such information as e.g. age, sex, lab and physical examination results, substance use, adverse events, medical history, drug administration etc.
The data might be recorded in the system with a certain delay, since some hospitals do not have web-enabled computers in consulting rooms.
The data in RAVE is prone to change as new findings are recorded and errors are corrected. Each study collects a different set of information, depending on the drug, disease and endpoints (safety/efficacy) under investigation.
CLIC
CLIC stands for Clinical Operations Information Center. It is a web-based utility that is fed with the information from IMPACT, IVRS, RAVE, Accord, Veeva and other systems and displays the data in a form of easily understandable charts and graphs.
The purpose of CLIC is to provide clinical operations, study teams and wider stakeholders with a single source of information where accurate, real-time study management and operational data is easily available to help drive performance and quality in clinical trials.
CLIC Study Dashboards are based on Spotfire, QlikView or BO Data Visualization & Analytics Software, configured to display high-level information on study progress.
Visualization of study progression charts in CLIC is possible on the condition that study level Enrollment and Study Sites Initiation Plans have been recorded in IMPACT.
Although, not only subject projections, but also actual number of patients is available in IMPACT, actual enrollment figures are directly imported from AZ IxRS system to ensure near real-time data flow.
MLCS
Master List of Clinical Studies (MLCS) is a database containing
all basic information about studies
recorded in IMPACT and
links to study related documents
, such as: CSPs, CSRs, sample CRFs, analysis data etc.
(if available)
.
It contains a build-in export tool suitable for combining basic study level data from single to multiple studies.
MLCS database captures changes in IMPACT xml export file and updates the data accordingly.
Substance Code
Therapeutic Area Code
Study Code
Study Status
Medical Unit
Study Protocol Title
Study Indication
Study Type
Study Phase
Actual dates: CSP approved; FSI, LSLV, CSR approved
Actual number of patients screened & enrolled
Min/Max age
List of countries
Enrollment
Enrollment plan (not required for outsourced studies)
Planned number of subjects (study & country levels)
Actual recruitment from study, site or subject level
Financial medical unit:
study level - should be set to the responsible R&D site or MC for the overall budget
country level - affects planned number of subjects visible in ACCORD
on site level - affects actual number of subjects visible in ACCORD
CDP level information
Code
Description
Type
Therapeutic Area
Study level information
Study Code
Study Description
Study Category
Alternative Code
Study Leader's name
Single Country Study status (yes/no)
Single Site Study status (yes/no)
Last Country Set Up status (yes/no)
Study Phase
Planned Study Sites
Planned number of subjects
IND Study status (yes/no)
Study status (cancelled/stopped/delayed)
Responsible Unit
Finance Medical Unit
IMPACT updating Unit
Data Management Unit
Therapeutic Area
Therapies: IP Code
Enrolment plan
Subject Visit Design
Planned dates

Study level
FSI
LSI
Primary Analysis
LSLV
DBL
SCA
Country level
FSI
LSI
LSLV
DBL

Actual dates
Study level
Primary Analysis
DBL
SCA
Country level
DBL
Site level
FSI (first date rolls up to study level)
LSI (last date rolls up to study level)
LSLV (last date rolls up to study level)
Data transfer:
every hour
captures changes in IMPACT xml export file
Data transfer:
monthly (1st-4th weekday of each month)
or ad hoc
entimICE-AZ (Entimo Integrated Clinical Environment for AstraZeneca) is a system configured by NNIT which replaced CSRE, A&RT and CAVE system
entimICE is an application used by Global Medicines Development, Early Clinical Development and Medimmune as a repositiory for clincal data

Data transfer:
daily
captures changes in IMPACT xml export files
Data transfer:
every hour
captures changes in IMPACT xml export file
Country level information
Country name
Confirmed Study Sites
Planned numbers of subjects
Country status (cancelled/stopped/delayed)
Responsible Unit
Finance Medical Unit
IMPACT updating Unit
Data Management Unit
Site level information
Site number
Facility details (adress, phone etc.)
Site status (cancelled/stopped/delayed)
Responsible Unit
Finance Medical Unit
IMPACT updating Unit
Company personnel details (name, occupation)

when MySites is used:
ePRO in use
Subject enrollment/randomization number
Informed consent version and date
Date of last visit
Subject withdrawal date, reason and description
JASPER
ANGEL
‘A New Global Electronic Library’ – is the Regulatory Information Management System and its approved collaborative partners.

ANGEL comprises three main components:
Document Management
- set of processes and technologies for creating, editing, reviewing, approving and storing documents within the ANGEL system. It provides controlled access to information, automates repetitive tasks, secures and protects the data held within the system.
Publishing
- is the process of preparing, compiling, validating and submitting regulatory information to Health Authorities (HA) across the globe. It can be:
Report Level Publishing
- compiling multiple elements of the report authored separately into one single document e.g. Clinical Study Agreement
Submission Publishing

- the process of adding documents to the submission template (eCTD, non-eCTD or paper) within the publishing tool, validate the submission and store it in the submission file share (repository)
Tracking
- is the set of processes for managing the overall progress of products, submission status, Health Authority Interactions and responses to Health Authority Questions

Data transfer:
Study must be manualy set up in Veeva Vault system to trigger data transfer
data transfer - once daily

System
: http://accord.rd.astrazeneca.net/
Sharepoint
: https://azcollaboration.sharepoint.com/sites/AB262/_layouts/15/start.aspx#/
Helpdesk
: ACCORDHelpdesk@astrazeneca.com
Links &
contacts:
Please note that:
Transfer occurs for all studies that are Active in IMPACT
There is
No
data transfer to PharmaCM for following : ISS, COST, and EXT studies (they will continue to be handled manually in PharmaCM)
Site locations will not be transferred for NIS, RWE and RDJ observational studies and they will be manually handled in PharmaCM
Actual number of randomised patients will transfer from IMPACT to PharmaCM when study milestone - actual LSLV is reached
Event dates:
M-First Subj In/Enrol FSI (Planned/Actual)
M-Last Subj In/Enrol LSI (Planned/Actual)
Primary Analysis LSLV (Planned/Actual)
M-Last Subject Last Visit (Planned/Actual)

AZRAND
ABBA
Links &
contacts:
PROJECT MANAGEMENT & BUDGETTING
SAFETY LETTERS
DISTRIBUTION

PATIENT DETAILS
SUBMISSION
CLINICAL TRIAL
TRANSPARENCY


AstraZeneca BioBank Application (ABBA) is a highly configured laboratory information management system for Human Biological Samples (HBS).

It is used to:
enable full traceability of the samples;
increase visibility of HBS to scientists;
integrate with clinical systems to provide characterization data for each sample;
improve compliance;
harmonize procedures across all AZ Biobanks.

Collected data includes but is not limited to: sample ID; E-code; collection date&time; sample form, condition; collected biofluid or organ; collection category, method; age at enrollment; sex; nicotine use and many others.
System
: https://planit.astrazeneca.net/PLANIT/
Sharepoint
: https://azcollaboration.sharepoint.com/sites/AE096/Pages/Home.aspx
Helpdesk
: https://azcollaboration.sharepoint.com/sites/AE096/Pages/Contact-and-support.aspx
Links &
contacts:
Forecasted internal and external costs
Internal actuals
Links & contacts:
Links &
contacts:
Data transfer:
daily (Monday to Friday)
Funding model (global/local)
Project hierarchy
Forecasted external costs
Actual external costs
FinD is the management reporting tool for R&D. This includes the RAW data warehouse, standard Business Objects reports and a forecasting tool.
FinD is used for the generation of expenditure reports and cost forecasting.
The application is based on SAP Business Objects environment.
System
: https://azcollaboration.sharepoint.com/sites/AB346/_layouts/15/start.aspx#/FinD/FinD%20Application%20Links.aspx
Sharepoint
: https://azcollaboration.sharepoint.com/sites/AB346/_layouts/15/start.aspx#/FinD
Helpdesk
: FinD-Helpdesk@astrazeneca.com
Links &
contacts:
Database: http://mlcs.astrazeneca.net:18001/MLCS/
Helpdesk: links on the database website
Links &
contacts:

EVENT ADJUDICATION DATABASE
Collection of all data (including source documents) needed to adjudicate events (define if event reflects endpoint protocol definition) by Clinical Events Committee.
Adjudication performed by external committee of physicians takes place.
Generation of adjudication documents required for regulatory submission, e.g. adjudication output datasets, event package PDFs, audit trail logs and Event Adjudication Regulatory Reports.
Links &
contacts:
Sharepoint:
https://azcollaboration.sharepoint.com/sites/SS137/EA/_layouts/15/start.aspx#/SitePages/Home.aspx
Helpdesk:
EventAdj@astrazeneca.com
Storage of adjudication data
Import of data related to endpoints and special interest events (eCRFs data).
Standardized Data (datasets) Storage
Submission documents
Data transfer:
frequency depends on study requirements
Data transfer:
manual, once
Data transfer:
daily
Data transfer:
manual, once
Sharepoint
: https://azcollaboration.sharepoint.com/sites/SS324/SitePages/entimICE-AZ%20Business%20Services.aspx
Helpdesk
:EAZ-SuperUsers@astrazeneca.com
Links &
contacts:
Sharepoint
: https://www.em.azcollaboration.com/rnd/Clinical/SnP/CP/COSE/SitePages/SE%20Systems%20-%20RAVE.aspx
Helpdesk
: RAVE-Global-Mailbox@astrazeneca.com
Links &
contacts:
MATCH/ClinPhone4
MATCH and ClinPhone 4 are IxRS Parexel Informatics systems. Throughout the different documents another abbreviations for IxRS can be found (like IRT or RTSM).
IxRS stands for
Interactive Voice/Web Response System.
IRT stands for
Interactive Response Technology.
RTSM stands for
Randomisation and Trial Supply Management
- which describes two main functionalities

of the system.
The system is used by Conditional (on site) Users: Investigator, Study Coordinator, Blinded/Unblinded Pharmacist, Monitor (CRA) and Unconditional (global) Users: Sponsor (Global Study Team), Supply Chain Study Manager, Blinded/Unblinded Depot.

Standard IxRS functionalities are:
activation of study (to open Enrollment/Randomization on a global level) and centers (to open Enrollment/Randomization on site level);
registration of basic patient data - Date of Birth, Gender (Enrollment - system is assigning E-code);
assignment of subjects to treatment arm (Randomization);
allocation of kit(s) to subjects (Dispensing) and verification if correct kit(s) have been taken (Kit Verification);
unblinding treatment (at center, country and global level);
registration of damaged or missing kit(s) (Confirm Shipment);
registration of subjects not eligible for randomization in the study (Screen Failure);
registration of withdrawn and completed subjects (Withdrawal/Completion).

Bespoke (non-standard) functionalities may be implemented in a system in accordance to study-specific requirements like: Pre-screening, Re-screening, Stratification/Cohort management
Data transfer:
real-time integration
Commonly chosen datapoints for integration:
Screening/Enrollment
Date of Birth
Inform Consent date
Enrollment Date
Gender
Screen-failure
Screen Failure Date
Randomization
Randomization Date
Dispensation (Scheduled, Unscheduled, Replacement)
Dispensation date
Completion/ Withdrawal
Completion/Withdrawal Date
IRT Data Feed - XML file containing cumulative data (study, centre, subject and visit information) for all ongoing trials. Each study will be configured to include one of the following sets of data:
BASIC
default set-up for all studies.
Does NOT include information pertaining to kits allocation, as this may be unblinding or partially unblinding for some protocols.
FULL
Includes kit allocation information, as it has been determined that this will NOT unblind or partially unblind patients data.
Sharepoint:
https://azcollaboration.sharepoint.com/sites/SS152/SSnSM/SitePages/globalBio.aspx
Helpdesk:
ClinicalBiobankBSR@astrazeneca.com

Links &
contacts:
Mailbox: IVRSIWRS-Support@astrazeneca.com
IRT Toolbox: https://www.em.azcollaboration.com/rnd/Clinical/SnP/CP/COSE/SitePages/SE%20Processes%20-%20IRT%20Toolbox.aspx
CDA Pack Data
CDA stands for ClinPhone Drug Accountability
Captures Kit dispensing dates and return dates from RAVE
Not commonly used
New AZ Randomization/unblinding solution, to replace GRand.
It is a fully outsourced solution provided by Parexel Informatics.
Has the ability to support complex study randomization designs, to generate Randomization Lists for the trials.
Gives the possibility to unblind subjects on global level by GPS (Global Patient Safety) or country level by LPS (Local Patient Safety).
Links &
contacts:
Mailbox: AZRand@PAREXEL.com
MySites is a site management tool used to document monitoring activities (on-site and remote visits) supporting our SOPs and ICH-GCP.
Prior to using MySites for the first time, there are few steps that must be completed in IMPACT Progress first:
Study and Country set up;
Site Set-up Prior to Site Qualification Visit;
Site Qualification Visit Conducted Using
MySites;
Site Confirmed, ISF Set-up and ISF Index Created, ePro Usage Confirmed, Subject Informed Consent Version Applied in Progress, Planned Site Recruitment Confirmed;
Initiation Visit Conducted Using
MySites


The following data recorded in Rave will be transferred to IMPACT:
Subjects (Enrolment Code)
Actual Visit dates
Withdrawal from Study date and Withdrawal reason
Milestones depends on PVD, study specific (Study Leader requests integration)

Data transfer:
Every hour

Data Transfer:
before FSI
Parexel Informatics sends randomization lists to biostatisticians for review and approval, then the list is uploaded to the system.
SAPPHIRE
It is a central AZ safety database that contains all safety reported information.
Reports are triggered from Sapphire and then displayed in Jasper as CIOMS, PSLL and ISL.
Sapphire integrates with some other systems, for example with Signal management system (SMS).
Contains expedited safety reports matching business rules (different for each country) and all PSLLs.
Enables Safety Report Distribution Team to submit these reports to appropriate destinations (distribution list displayed in Jasper according to the data in IMPACT).
Enables Safety Report Distribution Team tracking all produced, submitted and discarded reports (including DSURs).
Site level information:
- Distribution lists
- Site status -
key triggering milestones:
RA Approval (actual date)
FSI (actual date)
LSI (actual date)
LSLV (actual date)
Close Out Visit
- Clinical Personnel (PI)
- Site Location with correct purpose code
Sharepoint:
https://azcollaboration.sharepoint.com/sites/AB357/SitePages/Backup%20SAPPHIRE%20BOb%20JASPER.aspx

Helpdesk:
Sapphire.BusinessSupport@astrazeneca.com


CAP
Control of Investigational Product system (CAP) is the application used in R&D Supply Chain process.
CAP is a globally used application for:
Generating Kit Randomization data for studies
Exporting the Kit Randomization data to other systems (e.g. IxRS/MATCH, packaging/labelling system)
Printing the Kit Randomization data for downstream usage.
The information is provided to CAP by SCSM who receive the ‘CAP list request form’ from the team.
Event dates:
CSP Approval (Planned/Actual)
RA approval (Planned/Actual)
M-First Subj In/Enrol FSI (Planned/Actual)
M-Last Subj In/Enrol LSI (Planned/Actual)
M-Last Subject Last Visit (Planned/Actual)
Final DBL (Planned/Actual)
Planned Stats Complete (Planned/Actual)
CSR Approved (Planned/Actual)

Actual number of patients
CLIC homepage
: http://goto.az/clic
Helpdesk
: clicsupport@astrazeneca.com
Links &
contacts:
System
: https://impact-az.perceptive.com/production-webimpact/application/start.do
Sharepoint
: https://azcollaboration.sharepoint.com/sites/SS137/IMPACT/_layouts/15/start.aspx#/
Toolbox: https://azusgb01--c.na42.visual.force.com/apex/CLNMToolbox?itemid=a2qF0000000HU9CIAW
Mailboxes
:
outsourced studies: Global-EPMT-IMPACT-Support@astrazeneca.com
ESR studies: IMPACTWARSAW-HUB@astrazeneca.com
trainings and support: Impact.Global@astrazeneca.com​
Links &
contacts:
Data transfer
:
daily
Data transfer:
Every hour

*Subject information
E-Code
Randomization number
Gender
Milestones depends on PVD
Withdrawal date and reason if applicable
*Information about subject is integreted in case when integration is set- up
IMPACT sends XML files every day across the network to update ABBA system with all changes made to studies, centres, company personnel and milestones.

The following data are transferring to ABBA:
* IMPACT study level:
IMPACT study status, Study description, Protocol Title, Therapeutic Area, Substance, Clinical personnel and the dates from study level as actual and planned dates: 1st Subj In Act; LSLV Plan; LSLV Act; DB Lock Act; CSR Appr Plan; CSR Appr Act

* IMPACT country level:
Country names, site numbers

* IMPACT site level:
Facility and principal investigator number from IMPACT Investigational module

Data transfer:
every day
captures changes in IMPACT xml export file
future integration
future integration
future integration
Authors:
Alster Olga
Balcerek Kasper
Drabarek Beata
Kotlarska Aleksandra
Majcher Paulina
Makowska Małgorzata
Oroń Anna
Siwaszek Aleksandra
Ślęczka Anna
Stankiewicz Tomasz
Tepper Natalia
Wawrzycka Aleksandra
Wichowski Michał
Wotlińska Aleksandra

Quality check:
Czarnocki Rafał

Design & management:
Siwaszek Aleksandra

Administrators:
Drabarek Beata
Makowska Małgorzata
Siwaszek Aleksandra
Stankiewicz Tomasz
Note:
not all of AZ systems/utilities are now visible on the map. If you would like to add one or two systems yourself, please feel free to join our team!

We assume that this map will be updated regularly to give user-friendly and accurate picture of systems and utilities used within AZ. So, if you have any questions, suggestions or information that the map should be updated, please contact me via e-mail: aleksandra.siwaszek@astrazeneca.com or ask any other Administrator for assistance.

Please be aware that the Integration Map was designed for an
internal use only
. No legal department was consulted in the topic of sharing it to external stakeholders.
You can get around the map by using your mouse in a way similar to "drag and drop" move. To zoom in, click once on an object (system circle, arrow, text box with integration datapoints) or use your mouse scroll. To zoom out, click once on a background, use your mouse scroll or click right arrow on your keyboard. Use
right arrow
to begin.
Data transfer:
manual
Data transfer:
links to ANGEL documents are manually added to the MLCS database website
External costs -
Amounts invoiced to AZ by third parties and includes CRO costs, investigator payments and lab costs.
External costs
- amounts invoiced to AZ by third parties and includes CRO costs, investigator payments and lab costs.
Internal costs -
MC FTEs
Data transfer:
every hour
Data transfer:
manual
Pack List contains:
Kit ID
Verification letters
Treatment arm
Sequence number

Data transfer:
daily
captures changes in IMPACT xml export files
Links &
contacts:
Data transfer:
every 24 hours
captures changes in ESSROS xml export files

Sharepoint:
https://azcollaboration.sharepoint.com/sites/SS329/SitePages/Home.aspx
AZ clinical trials:
http://astrazenecagrouptrials.pharmacm.com/
Helpdesk:
ClinicalTrialTransparency@astrazeneca.com
System (document management)
: https://www.angelce.com/fdrd/component/main
Sharepoint
: https://azcollaboration.sharepoint.com/sites/AB157/SitePages/Home.aspx
Helpdesk
: ANGEL-Global-IS-Support@astrazeneca.com;
ANGELClinicalGRAPSQASupport@astrazeneca.com
Links &
contacts:
Veeva Vault eTMF:
https://login.veevavault.com/auth/login
Helpdesk: https://azcollaboration.sharepoint.com/sites/AZ007/SitePages/Home.aspx
Sharepoint:
https://azcollaboration.sharepoint.com/sites/SS137/CS/SitePages/Home.aspx
Helpdesk:
Store.Clin@astrazeneca.com
Links &
contacts:
System:
https://impact-az.perceptive.com/production-mysites/application/start.do
Helpdesk
: Impact.Global@astrazeneca.com
System:
http://jasper.rd.astrazeneca.net:7009/Jasper/doLogin.action
Helpdesk:
Sapphire.BusinessSupport@astrazeneca.com
Safety Distribution Team contacts:

PSLL--SUSAR-Distribution@astrazeneca.com
ISLAdministrator@astrazeneca.com - for US sites requiring Investigator Safety Letters distribution
Links &
contacts:
Links &
contacts:

CDP level information
Therapeutic Area
Investigational Product Code
Study level information:
Study Code
Study Status
Study Category
IND Study (yes/no)
Study Description
Protocol Title
Study Design (Blinding/Randomisation)
Indications
Therapies
Study Objective
Regulatory Reference
Company Personnel

Clinical Operations Enablement
Data transfer
:
daily
Data Feed: XML file containing cumulative data (study, centre, subject and visit information) for all ongoing trials.

SmartSupplies
SmartSupplies PMD (Planning, Materials and Distribution) is an easy to use, fully web based software solution that helps to effectively plan, monitor, control, and execute the clinical supplies process.
It provides a centralized, secure and compliant location to access and maintain essential information about the study supplies.
The request for drug shipment is made via IRT (MATCH/ClinPhone). The site details (address, drug recipient credentials) are imported from IMPACT.
SmartSupplies combines a protocol driven framework with intelligent MES (Manufacturing Execution System). AstraZeneca uses the PMD module for manufacturing, packaging, labellings, distribution and inventory management of clinical trials materials.
Data transfer
:
every hour
PAT (patient / treatment assessment) address
DD (drug delivery) address
IP drug recipient – “for attention of”
The integration is needed when AZ DPD (Drug Product Delivery) facility manages distribution to depots and sites for IRT (MATCH/ClinPhone) managed studies. To avoid manual entry of orders into SmartSupplies, files that can be automatically uploaded into the system are required to be received from IRT whenever orders are raised, cancelled and/or confirmed as received at their destination. In total 5 different file types are used:
Shipment Request (when shipment to a site from AZ DPD facility is raised by/in IRT)
Shipment Receipt Notification (when shipment to a site from AZ DPD facility is confirmed as received in IRT)
Shipment Cancellation (if a shipment to a site from AZ DPD facility is cancelled)
Transfer Request (when shipment to a depot from AZ DPD facility is raised by/in IRT)
Transfer Receipt Notification (when shipment to a depot from AZ DPD facility is confirmed as received in IRT)
Data transfer
:
real time
DRUG
DELIVERY

Data transfer:
Data is transfered to IBB file server and automatically loaded to entimICE using 'copy jobs'
REACT4
REACT4 is a web application that enables you to view and interact with clinical data as it emerges from an ongoing clinical study, or at specified static data cut points e.g. blind data reviews and end of study reporting data.
REACT4 plots the data associated with safety and efficacy profiles of the drug (AEs, laboratory and vital signs measurement over time, RECIST assessments, dosing events etc.).
Data for ongoing studies is read daily from SAS files held in CAVE. For internally run studies, these SAS files are themselves extracted from RAVE on a daily basis. For externally run studies, these SAS files are updated as frequently as agreed with the vendor. This raw data is uncleaned and unvalidated. The SAS files may be in AZ Raw, CDASH or SDTM formats.
Data for Blind Data Review (BDR) and End of Study time points comes from Reporting Database (RDB) AdAM-formatted SAS file datasets and makes use of derived data types and analysis flags that are contained within those data files and used in corresponding programmed Tables, Figures and Listings (TFLs).
Links & contacts:
System (Chrome browser only):
https://react.rd.astrazeneca.net/#/
Helpdesk:
REACTSUPPORT@astrazeneca.com
Data transfer:
Daily for ongoing
Fired manually for static timepoints
SENTRI
Links & contacts:
System (Chrome browser only)
: https://sentri.rd.astrazeneca.net/#/

SENTRI is a GxP-validated system that supports the TRISARC (Trial Safety Review Center) team in conducting a first line review of safety data from a medical perspective and the SLSR (Study Level Safety Review) Team in adding and monitoring the most siginificant outcomes of the regular SLSR meetings for a given SLSR data interval
SENTRI is used by the TRISARC team, Study Physicians and Medical Scientists to track, comment and review Serious Adverse Events and Adverse Events of Special Interest in the context of medical consistency.
SENTRI will provide an audit trail of any medical escalations, data queries and site answers in case of an audit or inspection.
Within SENTRI application, a user will find a link that would direct him/her to relevant clinical data visualisation modules within REACT4. No data is transferred between applications.
No
data transfer:
only a link within SENTRI
redirecting to relevant visualisation modules
EVIDENCE CONNECT
Evidence Connect is a study management system, powered by iEnvision.
Evidence Connect enables multi-level metrics, key performance measures, and strategic insights to be captured, reported, and communicated across the organization.
Users from local, regional, and global markets can enter projects into Evidence Connect at the planning phase, align projects to current strategic objectives, submit them for governance review, and track the progress of projects through closure. Evidence Connect enables multi-level metrics, key performance measures, and strategic insights to be captured, reported, and
communicated across the organization.

It stores following information for GMA managed study:
General Study information (D-code, study type, description, TA, indication etc)
Study Budget information
Study Publication
Study Milestones
Study Enrollment data
Country enrollment data

Sharepoint
: https://azcollaboration.sharepoint.com/sites/SS189/SitePages/Evidence%20Connect%20Training%20Centre.aspx
Helpdesk
: https://azprod.service-now.com/az/?id=form&table=incident&filter=active%3Dtrue&sys_id=-1&v=
Links &
contacts:


Regulatory References: FD, EudraCT No., NCT No., US IND No.
Data transfer:
daily

Information about project types:
D-code
Study Function- Responsible unit funding the study (funding source)
Classification- Invoice payer responsible for the cost type

Information about costs e.g.:
Cost type- Category of the costs required to execute a study
Start Milestone- The milestone for which the activity of the cost type has started
End Milestone - The milestone for which the activity of the cost type has ended
Study details e.g. Study Code, Study Status, Study Type Code
Milestones: Milestone Type, Planned Milestone Date, Actual Milestone Date
Recruitment data e.g. Entered Screening, Entered Treatment, Completed Treatment
AZ TrialGate
Contact:

Kerstin.Palo@astrazeneca.com
EventAdj@astrazeneca.com
AZ TrialGate is a SharePoint-based tool for collecting of source documents from sites and query management (related to source documents).
Used for studies where Event Adjudication Database does not have capability to collect source documents and manage queries.
Reviewed by monitors and Endpoint Office source documents are used for compiling event dossiers to feed Event Adjudication Database.


Data transfer:
Manual
Once per event adjudicaton
Dossiers for Electronic Adjudication



entimICE- AZ
Document transfer:
Monitoring Visit Reports e.g.
Initiation Monitoring Visit Reports
Qualification Monitoring Visit Reports
Closure Monitoring Visit Reports
Remote Monitoring Visit Reports
Follow-up letters

Information regarding Advers Event e.g. Event ID, AE start date
E-code
Date of randomisation
Veeva Medical CRM
Veeva Medical CRM (Customer Relationship Management) System is a global, cloud-based tool that allows for the detailed recording of meaningful scientific exchange between the MSLs (Medical Science Liaisons) and external experts, using the core functionality of the Veeva Sales CRM reconfigured for Medical. The system allows us to track and review all MSL/External Expert interactions in a consistent way.

Study details e.g. Study Code, Study Status, Study Description, Stusy Status
Therapeutic Area
Study Site Parameters
Facility name
Clinical Personel e.g. Prinicipal Investigator


Sharepoint
: https://azcollaboration.sharepoint.com/sites/AB219/SitePages/Home.aspx
Links &
contacts:
4 times per day
Data transfer:
Full transcript