The IIS Portal is the global, single point of access for ... · outcome and should Roche/Genentech...

Logging in ………………………………………………………………………………………………… 2

Registration ………………………………………………………………………………………………. 2

Study Submission ………………………………………………………………………………………… 3

Submission Questionnaire Details ……………………………………………………………………….

- Interventional Study Submission

- NIS – Primary Data Collection Submission

- NIS – Secondary Data Use Submission

- NIS – Patient Chart Review Submission

5

5

7

8

9

Definition of Roche/Genentech Terminologies………………………………………………………….. 10

Table of Contents

IIS Sponsor Reference Guide

The IIS Portal is the global, single point

of access for all IIS submissions

Introduction | IIS Portal

User ID

› Go to roche.com

› Navigate to the IIS Portal entry page

› Begin the registration by clicking here

› Upon registration, you will receive two email

1. An email with a confirmation of your user ID

2. An email with your temporary password

› Enter your User ID, your temporary password and

click ‘login’

NOTE: Make sure you amend your password upon

logging in for the first time.

You need to first register for the Roche Investigator Initiated Studies Portal

You will be receiving a temporary user ID by email

› Enter your user details

NOTE: The person submitting does not necessarily

have to be the investigator, it could be an

administrator, study coordinator, etc. However

during the submission process the name and

address of the investigator must be documented

including the investigator CV. Anyone from the

sponsor institution can be submitting the concept.

User Details

Dr.

John

Sample

Sample Organization

+1 234 123 1234

Registration Overview

On the welcome page

› Click ‘New Study’ to submit a new study

In order to submit an activity, the scope must be

either:

› To generate scientific or medical evidence which

includes:

– Answering a clinical scientific

question, and/or

– Collecting clinical outcomes, and/or

– Collecting safety and/or

efficacy/effectiveness data

OR

› To generate health economic evidence. Neither

primary nor secondary endpoints can be safety

or efficacy.

Should you have any questions regarding the above,

please contact:

› [email protected]

› Select “New Study”,

› Accept the terms and conditions. You will now

be guided through a series of questions to

determine the correct submission questionnaire.

Study Submission

› The submission happens in 3 steps starts with a high-level Concept summary including a small number of questions.

Upon Concept Interest, you will be required to submit the Synopsis including the full budget and study timelines.

Upon Synopsis approval, you will be invited to submit the Protocol. Information on the different study types can be

found on page 10 of this reference guide.

› Concept submission will be reviewed collectively by the Roche/Genentech Review Committee based on scientific

merit and alignment with corporate research and development plans. The requester will be informed about the

outcome and should Roche/Genentech be interested in the concept submission, the investigator will be contacted

and invited to submit further details and a final protocol on the IIS in order to be considered for full approval.

mailto:[email protected]

Question 1:

›Are you conducting a research that is involving

interventions on human subjects outside of the

routine clinical care?

– If yes, choose “Interventional” in the

‘Request Type’ and choose the

respective Study Design that fits the

activity. The system will then

automatically assign the “Interventional

Questionnaire Submission Form”

– If no, choose “Non-interventional” from

the ‘Request Type’ and answer the next

question

Question 2:

›Are the date generated/collected for the specific

purpose of this activity as described in the protocol?

– If yes, choose “Primary Data Collection”

from the ‘Study Design’. The system will

then automatically assign the “Primary

Data Collection Questionnaire

Submission Form”

– If no, then answer the next question.

Question 3:

›Is this a Patient Chart Review?

– If yes, select “Patient Chart Review” for

‘Study Design’. The system will then

automatically assign the “Patient Chart

Review Questionnaire Submission

Form”.

– If no, select “Secondary Data Use” from

the ‘Study Design’. The system will then

automatically assign the “Secondary

Data Use Questionnaire Submission

Form”.

Submission Questionnaire Details

Interventional Study Concept Submission

Please note that the questionnaire can be saved at any

time as long as the field “Study Title” is completed. You

can leave the work at any time after saving and come

back later. Once saved, you will receive a temporary

tracking number.

Main Tab

* Single or Multi Site Study

* Single or Multi Country Study

* Countries in which the study will be run (tick boxes)

* Study Title

Short Title

* Therapeutic Area of the Product (drop-down list)

If ‘Oncology’, then

* Indication in the Study

* Tumor Type

* Tumor Stage

* Roche/Genentech Primary Product (drop-down list)

If ‘Other, not listed’, then

* Please indicate Product

* How you know this Product

* If you have contacted anybody at Roche/Genentech about

this study

If ‘yes’, then

* Please let us know who you have contacted

* Is this a Pediatric Study (Yes or No)

* Primary Investigator Details

Study Concept Tab

* Summary of the Concept

* Estimated Number of Patients

* Estimated Treatment Duration (per patient, in

cycles, weeks, etc.)

Support Tab

* Funding Request

* Drug Product Request

* Foundation Medicine Services Request

* Biomarker Request

* Material Request (other material, not related to

drug product or biomarkers)

* Information if you are requesting or receiving

support from other entities

Attachment Tab

You can upload additional supporting material if

you wish.

* = field is mandatory for submission


Interventional Study Synopsis Submission

Note: Previously submitted information in Main Tab and

Concept Tab remain locked and cannot be changed.

New questions

Main Tab

* Sponsor/Study Initiated Details

Study Synopsis Tab

* Upload your synopsis

* Enter Study Timelines:

– First Subject In

– 50% Enrollment

– Last Subject In

– Last Subject Into Treatment

– Last Subject Out of Treatment

– Completion of Final Study Report

– Estimated Abstract Submission

– Estimated Manuscript Submission

Support Tab

Update Support Request if required

* Upload Budget


Interventional Study Protocol Submission

Note: Previously submitted information in all Tabs remain

locked and cannot be changed.


Protocol Tab

* Attach full protocol



NIS – Primary Data Collection Concept Submission





tracking number.

Main Tab

* Is this a Registry (Yes/No)

* Single or Multi Site Study

* Single or Multi Country Study

* Countries in which the study will be run (tick boxes)

* Study Title

Short Title


If ‘Oncology’, please choose *Disease Area

* Is there a Roche/Genentech Product studies (tick boxes)

If yes, then indicate the Products (tick boxes)

- If ‘Other Product’ then please indicate the name of

the Product

* If you have contacted anybody at Roche/Genentech about

this study

If ‘yes’, then



Attachment Tab

You can upload additional supporting material

if you wish.

Study Concept Tab

* Summary of Project

* Estimated Number of Subjects

* Estimated Treatment Duration (if applicable)

* Estimated number of Data Sources (if

applicable)

Support Tab

* Funding Request


* Additional Support Request (e.g. data,

databases etc.)



NIS – Primary Data Collection Synopsis Submission



New questions

Main Tab


Study Synopsis Tab



- First Data Collection

- Last Data Collection

Support Tab

- Update Support Request if required

* Upload Budget


NIS – Primary Data Collection Protocol Submission

SubmissionNote: Previously submitted information in all tabs remain

locked and cannot be changed.


Protocol Tab




NIS – Secondary Data Use Concept Submission





tracking number.

Main Tab

* List of Country Population (tick boxes)

* Do you have permission to use the data (Yes/No)

* Study Title

- Short Title


- If ‘Oncology’, please choose *Disease Area

* Is there a Roche/Genentech Product studied (tick boxes)

- If yes, then indicate the Products (tick boxes)

- If ‘Other Product’ then please indicate the

name of the Product

*If you have contacted anybody at Roche/Genentech about

this study

- If ‘yes’, then



Attachment Tab


if you wish.

Study Concept Tab





applicable)

Support Tab

* Funding Request



databases etc.)



NIS – Secondary Data Use Synopsis Submission



New questions

Main Tab


Study Synopsis Tab





Support Tab


* Upload Budget


NIS – Secondary Data Use Protocol Submission

SubmissionSubmissionNote: Previously submitted information in all tabs remain

locked and cannot be changed


Protocol Tab




NIS – Patient Chart Review Concept Submission





tracking number.

Main Tab

* Is this a Registry (Yes/No)

* Single Country or Multi Country Study

* List of Countries in which the Study is being run (tick boxes)

* Study Title

- Short Title


- If ‘Oncology’, please choose *Disease Area

* Is there a Roche/Genentech Product studied (tick boxes)

- If yes, then indicate the Products (tick boxes)

- If ‘Other Product’ then please indicate the

name of the Product

*If you have contacted anybody at Roche/Genentech about

this study

- If ‘yes’, then



Attachment Tab


if you wish.

Study Concept Tab





applicable)

Support Tab

* Funding Request



databases etc.)



NIS – Patient Chart Review Synopsis Submission



New questions

Main Tab


Study Synopsis Tab





Support Tab


* Upload Budget


NIS – Patient Chart Review Protocol Submission

SubmissionSubmissionSubmissionNote: Previously submitted information in all tabs remain

locked and cannot be changed


Protocol Tab


Definition of Roche/Genentech Terminologies:

Terminology Definition

Interventional Study

Interventional Study (or Clinical Trial) is a clinical study in which participants

are assigned to receive one or more interventions (or no intervention) so that

researchers can evaluate the effects of the interventions on biomedical or

health-related outcomes. The assignments are determined by the study

protocol. Participants may receive diagnostic, therapeutic, or other types of

interventions. (Source: ClinicalTrials.gov)

Non-Interventional Study

NIS are carefully designed and conducted epidemiological studies, specifically

observational (non-interventional, non-experimental). In observational studies,

the investigator “observes and evaluates results of ongoing medical care

without 'controlling' the therapy beyond normal medical practice.”* For EEA

Affiliates, please refer to the definition below from EMAGVP Module VIII: A

non-interventional study is a study fulfilling, cumulatively, the following

requirements:

1. The medicinal product is prescribed in the usual manner in accordance

with the terms of the marketing authorisation;

2. The assignment of the patient to a particular therapeutic strategy is not

decided in advance by a trial protocol but falls within current practice;

3. No additional diagnostic or monitoring procedures are applied to the

patients above those applied in course of routine clinical practice; and 4.

epidemiological methods are used for the analysis of collected data.

* Sources: CIOMS, Current Challenges in Pharmacovigilance: Pragmatic

Approaches. Report of CIOMS Working Group V. Geneva; World Health

Organization (WHO), 2001 and FDA Guidance for Industry E2E

Pharmacovigilance Planning, 2005.

Note: The prescription of the medicine is clearly separated from the decision

to include the patient in the study.

Primary Data CollectionPatient level data collected after study initiation for the specific purposes of

the study, directly from healthcare professionals, caregivers or patients.

Secondary Data Use The use of data collected for purposes outside of the objectives of the study.

Patient Chart Review

Use of previously collected, identified and/or identifiable patient charts (paper

and/or electronic) to extract data into a study database.

If third parties access identified and/or identifiable patient charts and provide

patient cohorts with de-identified data to Roche in order to conduct SDU NIS,

Roche must obtain evidence of the third parties’ IRB/IEC approval for handling

identified and/or identifiable patient data.

If a computer algorithm creates a dataset of de-identified data from electronic

records, and the study team, including third party, is never exposed to

identified/identifiable data, then this study does not qualify as patient chart

review.

The IIS Portal is the global, single point of access for ... · outcome and should Roche/Genentech...

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