IIS Sponsor Reference Guide The IIS Portal is the global, single point of access for all IIS submissions Table of Contents 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 Page 1
Introduction IIS Portal You need to first register for the Roche Investigator Initiated Studies Portal You will be receiving a temporary user ID by email Registration Overview Go to roche.com Navigate to the IIS Portal entry page Begin the registration by clicking here User Details 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. Dr. John Sample Sample Organization +1 234 123 1234 User ID 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. Page 2
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. 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: OR Answering a clinical scientific question, and/or Collecting clinical outcomes, and/or Collecting safety and/or efficacy/effectiveness data 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: support.iisportal@roche.com Select New Study, Accept the terms and conditions. You will now be guided through a series of questions to determine the correct submission questionnaire. Page 3
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. Page 4
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. * 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.) * 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. Page 5
Submission Questionnaire Details Interventional Study Synopsis Submission Note: Previously submitted information in and Concept Tab remain locked and cannot be changed. New questions * 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 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 Page 6
Submission Questionnaire Details NIS Primary Data Collection 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. * 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 * Therapeutic Area of the Product (drop-down list) 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 * Please let us know who you have contacted * Primary Investigator Details Study Concept Tab * Summary of Project * Estimated Number of Subjects * Estimated Treatment Duration (if applicable) * Estimated number of Data Sources (if applicable) * Funding Request * Foundation Medicine Services Request * Additional Support Request (e.g. data, databases etc.) * Information if you are requesting or receiving support from other entities Attachment Tab You can upload additional supporting material if you wish. NIS Primary Data Collection Synopsis Submission Note: Previously submitted information in and Concept Tab remain locked and cannot be changed. New questions * Sponsor/Study Initiated Details Study Synopsis Tab * Upload your synopsis * Enter Study Timelines: - First Data Collection - Last Data Collection - Update Support Request if required * Upload Budget NIS Primary Data Collection Protocol Submission Submission Note: Previously submitted information in all tabs remain locked and cannot be changed. Protocol Tab * Attach full protocol Page 7
Submission Questionnaire Details NIS Secondary Data Use 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. * List of Country Population (tick boxes) * Do you have permission to use the data (Yes/No) * Study Title - Short Title * Therapeutic Area of the Product (drop-down list) - 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 * Primary Investigator Details * Please let us know who you have contacted Study Concept Tab * Summary of Project * Estimated Number of Subjects * Estimated Treatment Duration (if applicable) * Estimated number of Data Sources (if applicable) * Funding Request * Foundation Medicine Services Request * Additional Support Request (e.g. data, databases etc.) * Information if you are requesting or receiving support from other entities Attachment Tab You can upload additional supporting material if you wish. NIS Secondary Data Use Synopsis Submission Note: Previously submitted information in and Concept Tab remain locked and cannot be changed. New questions * Sponsor/Study Initiated Details Study Synopsis Tab * Upload your synopsis * Enter Study Timelines: - First Data Collection - Last Data Collection - Update Support Request if required * Upload Budget NIS Secondary Data Use Protocol Submission SubmissionSubmission Note: Previously submitted information in all tabs remain locked and cannot be changed Protocol Tab * Attach full protocol Page 8
Submission Questionnaire Details NIS Patient Chart Review 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. * 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 * Therapeutic Area of the Product (drop-down list) - 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 * Primary Investigator Details * Please let us know who you have contacted Study Concept Tab * Summary of Project * Estimated Number of Subjects * Estimated Treatment Duration (if applicable) * Estimated number of Data Sources (if applicable) * Funding Request * Foundation Medicine Services Request * Additional Support Request (e.g. data, databases etc.) * Information if you are requesting or receiving support from other entities Attachment Tab You can upload additional supporting material if you wish. NIS Patient Chart Review Synopsis Submission Note: Previously submitted information in and Concept Tab remain locked and cannot be changed. New questions * Sponsor/Study Initiated Details Study Synopsis Tab * Upload your synopsis * Enter Study Timelines: - First Data Collection - Last Data Collection - Update Support Request if required * Upload Budget NIS Patient Chart Review Protocol Submission SubmissionSubmissionSubmission Note: Previously submitted information in all tabs remain locked and cannot be changed Protocol Tab * Attach full protocol Page 9
Definition of Roche/Genentech Terminologies: Terminology Interventional Study Non-Interventional Study Primary Data Collection Secondary Data Use Definition 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) 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. Patient level data collected after study initiation for the specific purposes of the study, directly from healthcare professionals, caregivers or patients. The use of data collected for purposes outside of the objectives of the study. Use of previously collected, identified and/or identifiable patient charts (paper and/or electronic) to extract data into a study database. Patient Chart Review 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. Page 10