requesting inform services

Imperial Clinical Trials Unit

REQUESTING INFORM SERVICES Form Number

IN021

IN021 – Effective 9th April 2015 of 7

STANDARD OPERATING PROCEDURE

SOP No. IN021.1

REQUESTING INFORM SERVICES

Effective Date: 9th April 2015

Prepared by: Name:

Title: Signature: Date:

Sandra Griffiths Head of ICT, ICTU

Approved by: Name:

Title:

Signature: Date:

Amanda Bravery

Development Team Leader, ICTU

Approved by: Name:

Title:

Signature: Date:

Professor Deborah Ashby

Co-Director, ICTU

Approved by: Name:

Title:

Signature: Date:

Virginia Picot

QA Manager, ICTU



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CONTENTS

Page

Contents

REQUESTING INFORM SERVICES ....................................................................................... 1 1. Introduction ............................................................................................................... 3

2. Scope ....................................................................................................................... 3 3. Abbreviations ............................................................................................................ 3 4. Responsibilities ........................................................................................................ 3 5. References ............................................................................................................... 4 6. Procedures ............................................................................................................... 4

6.1 Requesting an estimate ...................................................................................... 4 6.1.1 Information required from Investigator – non-commercial studies................ 4 6.1.2 Information required for Commercial Studies ............................................... 5

6.1.3 Clarification as necessary ............................................................................ 5 6.1.4 Preparation of estimate – non-commercial studies ...................................... 5 6.1.5 Preparation of estimate – commercial studies ............................................. 5

6.1.6 Provision of estimate – non-commercial studies .......................................... 5

6.1.7 Provision of estimate – commercial studies ................................................. 5 6.1.8 Funding request – non-commercial studies ................................................. 6

6.2 Requesting Study Database design, build, testing and support ......................... 6

6.3 Requesting Data Extracts ................................................................................... 6 6.4 Requesting Database Lock ................................................................................ 6

6.5 Requesting role based training ........................................................................... 7 6.6 Requesting user support .................................................................................... 7

7. Revision History ....................................................................................................... 7 Appendix 1. Sample Estimate ...................................................................................... 8

Appendix 2. Delegation of Responsibilities ................................................................. 10

Associated Forms / Templates

Pages



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1. Introduction

The purpose of this document is to describe how Investigators can request the services provided by the ICTU InForm team. The InForm system is an Electronic Data Capture (EDC) tool that provides electronic case report forms (eCRFs); on-line data entry, monitoring and data sign-off; reporting and data extracts for each study.

2. Scope

The services provided by the ICTU InForm team are primarily around the provision and support of study EDC tools and encompass the following:

Provision of an estimate for the build of a database to capture study data

Design and build of a study specific database

System testing of the study specific database

Provision of role based training for site and centralised study team members

Provision of user support for the duration of the study

Provision of data extracts for committees and analyses

Secure data storage, backup and recovery facilities

3. Abbreviations

AHSC Academic Health Science Centre ICTU Imperial Clinical Trials Unit IMP Investigational Medicinal Product eCRF Electronic Case Report From EDC Electronic Data Capture JRO Joint Research Office JRCO Joint Research Compliance Office CRF Case Report Form CSV Comma Separated Variables RDE Reporting Data Extract

UAT User Acceptance Testing

ICT Information and Communication Technologies

4. Responsibilities

Investigator or delegate Requests estimate for study

Informs the team when funding has been obtained

Provides protocol and draft requirement

Signs delegation of responsibilities form

Commercial Operations Manager or delegate

Requests estimate for study

Provides protocol for funded studies

Creates requirements documentation

Head of ICT, ICTU or deputy

Provides estimates upon request

Oversees the InForm team and processes



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InForm team Designs, develops and tests study

Liaises with ICT for release of study

Provides support through lifecycle of study

Processes requests for data extracts

Processes requests for database lock

InForm trainer Delivers training

Ensures all required certification and documentation provided for users

5. References

a. JRCO/SOP/007 Case Report Forms (section 3.5) b. ICTU SOP IN014 User Support c. ICTU SOP IN007 Database Lock d. ICTU SOP IN010 End User Training e. ICTU SOP IN004 Requirements Definition for InForm Trials f. ICTU IN_UG_013 Reporting Data Extract (RDE) Request

6. Procedures

6.1 Requesting an estimate

The use of InForm has been mandated for all Imperial College AHSC sponsored clinical trials of an IMP, however other studies may request the use of the InForm system. Each request for an estimate will be assessed against existing library forms plus other relevant information and a tailored estimate will be provided.

6.1.1 Information required from Investigator – non-commercial studies

A request for an estimate to provide a study specific EDC system should be sent to [email protected] providing an outline of the proposed study or protocol if possible that provides information about the design and data capture requirements for the study. If not available then the following information will be required:

a. Complexity of the study i. High – >3 dynamic forms/visits1, > 4 randomisation arms, complex

calculation, special access controls2 ii. Medium – <3 dynamic forms/visits, complex calculations and 2- 4

randomisation arms iii. Low –simple calculations and up to two randomisation arms

b. Duration c. Number of sites/users (assumption is 2 users per site plus at least 1

central user for monitoring, if more sites then more monitors will be needed)

1 Dynamic forms/visits are those that are generated based on data entered, e.g. pregnancy only being presented

for female subjects or visit frequency/measurements different dependent upon the Arm of the subject. 2 Special access controls are used when read and/or write access to some data items is restricted e.g. lab results

which may result in study teams being unblinded

mailto:[email protected]



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d. Number of visits e. Randomisation requirements

i. Automated or manual randomisation ii. Automated unblinding

f. High level data collection requirements g. Number of data extracts required if more than 2 required per year

6.1.2 Information required for Commercial Studies

The commercial operations manager (or designate) will request an estimate providing the information as detailed in 6.1.1 above. Any additional requirements, such as extra assistance with randomisation; pre-formatting of data extracts etc. will need to be detailed along with timescales for turnaround.

6.1.3 Clarification as necessary

Based on the information provided by the Investigator or commercial operations manager it may not be possible to give a realistic estimate. In this case then a telephone or face to face conversation may be required to ensure that the appropriate data collection and services have been identified. If the Investigator has some paper CRFs from a previous study this may help clarify what is needed.

6.1.4 Preparation of estimate – non-commercial studies

Using the information provided and review of data collection requirements against existing library forms, an estimate will be generated using a pre-approved template. See Appendix 1 for an example of the resulting estimate. A copy of the estimate will be placed on the InForm team SharePoint site.

6.1.5 Preparation of estimate – commercial studies

The same process will apply to the preparation of the estimate but there are increased licencing costs and hourly rates for commercial studies and a separate template is used. A copy of the estimate will be placed on the InForm team SharePoint site.

6.1.6 Provision of estimate – non-commercial studies

The estimate will be sent by email to the Investigator (or delegate); the JRO team assigned to the Investigators department and department administrators for information purposes. The Investigator (or delegate) should review the estimate to ensure that the assumptions made are correct. Any changes should be requested and a revised estimate will be provided based on the changes with a copy updated to SharePoint.

6.1.7 Provision of estimate – commercial studies

The estimate will be sent by email to the commercial study team for inclusion in the bid for work. The estimate should be reviewed to ensure that all requirements have been met. Any changes should be requested and a revised estimate will be provided and updated to SharePoint



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6.1.8 Funding request – non-commercial studies

Once the estimate has been agreed it should be added into the proposal for funding of the study. The majority of the work is done in the first year of the study and the InForm team will require the release of funds during this period.

6.2 Requesting Study Database design, build, testing and support

The Investigator or commercial operations manager should advise the ICTU InForm team as soon as the study funding is agreed by email to [email protected]. The study will then be added into the pipeline; if a provisional go-live date is available this should also be provided. Upon receipt of an email confirming funding, the ICTU team will supply the Investigator or commercial operations manager with a delegation of responsibilities form for completion (see Appendix 2). The study will be added to the pipeline of work and an initiation meeting will be scheduled once a draft protocol is available. The study will be built and tested to the specification as defined in the InForm Requirements template for the study. Please refer to reference e for details of the requirements gathering process. Following successful completion of User Acceptance (UAT) the study will be scheduled for release to the Production environment. The InForm team provide support to studies until they are archived from the Production environment. Reference b provides details of how support is requested.

6.3 Requesting Data Extracts

The InForm system has a utility that extracts all the data into a Reporting Data Extract (RDE). This extract is normally used by statisticians for the purposes of reporting and analysis. The RDE is provided in Comma Separated Variable (.csv) format that can be imported into Microsoft Excel or other such analysis packages. Reference f provides details on how to request and receive the RDE.

6.4 Requesting Database Lock

Database lock normally occurs at the end of the study. There are two types of lock, a soft lock which is a pre-cursor to the final, hard lock. A soft lock is applied where no edit access to the data is permitted; the study statistician will request an RDE and perform a first cut analysis identifying any issues with the data. The study team will review the issues identified and correct where possible. The hard lock will be applied when there is no further edit access to the database required. Nominated study team members will be provided with read-only accounts for reporting or data checking purposes. Reference c provides details of the database lock process.




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6.5 Requesting role based training

The InForm team provides role based training either by e-learning or by face-to face sessions. Face-to-face sessions may be conducted in person or via remote sessions using an appropriate tool. Reference b provides details on types of training and how to request.

6.6 Requesting user support

The InForm team provides user support during normal UK working hours (9 – 5) either by email or telephone. Users should provide details of the study they are working upon in addition to the study name and what the support item is. A number of user guides have been prepared to assist the users in resolving common issues such as password recovery/reset, how to randomise a patient etc. Copies may be requested from the InForm trainer. Newsletters are produced on a regular basis and contain useful information; copies are available on the ICTU web site.

7. Revision History

SOP Ref. Date Effective Reason for update

First version



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Appendix 1. Sample Estimate

Estimate 0

0

Effort Days Cost

Design 4.7 1,601.40

Development 3.9 1,339.60

Documentation 0.1 47.60

Testing 8.9 3,022.60

Reporting 0.8 272.00

Project Management 1.8 628.32

Hardware/Software contribution 2,941.00

ICT Costs (Backup, Disaster Recovery Provision) -

Data Management (RDE and data cleansing for duration of trial) -

-

User Support (2 x 2 hour calls per year per user for duration of trial) 0.0 -

Training assistance 0.0 -

Contingency 2.0 691.15

Grand Total 22.4 10,543.67

n.b. The 'Days' column contains working days, not elapsed time



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Assumptions

x Sites

y site users plus 2 central users

p Library Forms

System Screening/Enrolment

Demographics

Vital Signs

Medical History

AE/CM

End of Study / Termination

Protocol Deviation

r Library forms with amendments

Inclusion/Exclusion

s New Forms

New form 1

Randomised to z Arms

Study duration of A years

t Visits

Baseline

End of Study



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Appendix 2. Delegation of Responsibilities

DELEGATION OF RESPONSIBLITIES BETWEEN

Chief Investigator &

ICTU InForm Team for CLINICAL TRIALS OF INVESTIGATIONAL MEDICINAL PRODUCTS

This form acts to identify and acknowledge responsibilities between the designated Chief Investigator undertaking clinical trials Involving Medicinal Products (IMPs) as defined by the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Imperial Clinical Trials Unit InForm team.

Title of Research Project:

Chief Investigator: EudraCT:

Trial Statistician: JRCO Ref:

Account/Award Number:

Phase

Drug(s) or device being used:

Licensed?

Therapeutic Area: No. of sites

RESPONSIBILITIES OF IMPERIAL CLINICAL TRIALS UNIT (ICTU) InForm team

General Provide training materials and deliver training (face-to-face or e-learning)

Maintain details of user training certificates

Maintain records of User Activation Forms

Provide input to audits or inspections as required

Maintain InForm Data Management File

Study trial build Organise InForm trial build initiation meeting

Provide templates and user guides for requirements and master user list

Review and provide feedback on requirements within one week

Develop database forms

Conduct structured walk through

Finalise development and build rules, validations and alerts

Document and run system test scripts

Provide test trial for User Acceptance Testing

Provide Annotated Study Book for trial team and statistician

Liaise with ICT for release of Live trial following User Acceptance Testing sign-off

Provide trial release pack for Chief Investigator sign-off and filing

Activate any live sites/users once trial has been released and checked

During the study

User support via telephone or e-mail

Meeting to discuss any changes



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Develop trial changes

Update and run test scripts for changed trial

Provide changed trial for User Acceptance Testing (UAT)

Provide Annotated Study Book for trial team and statistician

Liaise with ICT and trial team for release of changed trial following UAT sign-off

Co-ordinate down time to live trial

Provide Go Live acceptance pack for Chief Investigator sign-off and filing

Liaise with ICT for data extract requests and provide reports as appropriate

Process data load requests (if implemented)

Process requests for minor changes to randomisation database

User and site maintenance

Maintain site activation log

Transfer patient data between sites

End of study Schedule database lock

Provide datasets and prints upon archiving

Provide support to data sharing if required



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RESPONSIBILITIES OF CHIEF / PRINCIPAL INVESTIGATOR

General Ensure all team members receive role specific training on the InForm system, including User Acceptance test team

Ensure trial team establish a generic email address for safety reporting email alerts from the InForm system

Study trial build Final version of protocol provided to InForm team

Attend trial initiation meeting

Complete and return trial requirements documentation

Attend structured walk-through of trial InForm database prior to development of rules and validations.

Respond to queries/questions within two weeks

Ensure randomisation information is supplied if applicable

Review Annotated Study Book against protocol

Sign-off trial requirements

User Acceptance Testing – customise test template and carry out tests

Sign-off User Acceptance Testing

Provide Master User List for sites and trials

Sign-off Go Live acceptance documentation

Ensure all team members provide User Activation Forms once trial and sites are ready to start recruitment

Ensure all InForm related trial documents are maintained in a Trial Master File (please note that the index will be updated following consultation with JRCO and published by May 2014)

During the study

Give notice of amendments to protocol and provide an updated version

Document any changes, whether or not related to protocol changes

Respond to queries/questions within one week

Sign-off changed requirements

User Acceptance Testing changes

Advise of any changes to trial team (e.g. leavers, new team members, changes of role)

Sign-off User Acceptance Testing changes

Agree suitable downtime for application of changes

Sign-off Release of changes

Complete documentation for patient transfers between sites

Provide 5 working days notice for data extract

End of study Advise of database lock and complete form

Advise of database archiving and complete forms

Provide details of any data sharing requirements



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Signature Print Name Date

CI

Signed on behalf of ICTU InForm team

Copies must be received by the Head of ICT, ICTU before trial build can commence. Email: [email protected] Originals should be sent by post for the Head of ICT, ICTU to counter sign.


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