Pharmaceutical Regulatory Information System (PRISM)
Contents
1. Systems Pte Ltd PRISM User Manual For Internet CT Expedited Safety Report Ver 1 1 1 Introduction Purpose The purpose of this user manual is to ensure that all nominated application users will be proficient in the use of the online application system Scope The scope of the manual is to provide information on the use of CRIS Administrator function Mapping of HSA Pin users to CT Protocol No Overview This document provides brief details on the standards and guidelines that a user should adhere to in doing mapping of HSA Pin users to CT Protocol No It divides the application procedure into sections and provides the brief guidelines for each of them HSA NCS Confidential Page 4 of 7 Copyright 2008 National Computer Systems Pte Ltd PRISM User Manual For Internet CT Expedited Safety Report Ver 1 1 2 Function 2 1 Mapping of HSA Pin users to CT Protocol No Steps 1 Only CRIS administrator can access this module 2 Please access the following URL DO NOT click on link please copy the URL to address bar of browser http eservice hsa gov sg osc portal isp AA process jsp eService 191 SjngPass Rs Terms ot ise EADs Hele Mhout ths 2 1 1 Login 1 Fill in your SingPass ID and password and click the Submit button 2 The predefined roles of the users comprising of drafter submitter CRIS administrator counter staff will be verified against the CRIS authorisation 3 Upon successful authenti2. A website without MSA s prior written consent 4 You may not set robots crawiers software agents or any other agents and or devices to retrieve data from the IA website or database Cras Statement Iama atise Meal Sciences Abra 2007 ait Rights Aerenea zl HSA NCS Confidential Page 6 of 7 Copyright 2008 National Computer Systems Pte Ltd PRISM User Manual For Internet CT Expedited Safety Report Ver 1 1 2 2 Form of Mapping of HSA Pin users to CT Protocol No Consumer Access Business amp Service Access SA prism hsa Business amp Service One Stop e Services HSA PIN CTC Protocol No Mapping Adding Mapping Drafter SingPass ID v 9 H0000091 hsapin Staf Protocol Title A Phase 2 Study of XYY Y12345 in Patients with Metastatic Non Small Cell Lung Cancer w Effective Start Date 14 03 2008 3 ca Effective End Date 31 03 2009 2 List of HSA PIN Protocol Mapping 1 matching record s found Page Page 1 of 4 First Previous Next Last Protocol Protocol Title Eff Date End No Date O1 H0000091 XY0001 APhase 2 Study of XXXYYY12345 in Patients with Metastatic Non Small Cell 14 03 2008 Lung Cancer 31 03 2009 1 matching record s found Page Page 1 of 1 First Previous Next Last You may close this window after add or remove the mapping This section shows the list of existing mapping of HSA Pin and Clinical Trial Protocol Number I
3. AT Health Sciences Authority Pharmaceutical Regulatory Information System PRISM Internet Mapping of HSA Pin users to CT Protocol No Module User Manual Version 1 1 October 2008 ncs HSA NCS Confidential Page 1of7 Copyright 2008 National Computer Systems Pte Ltd making IT happen PRISM User Manual For Internet CT Expedited Safety Report Ver 1 1 REVISION HISTORY Effective Summary of Changes Date March 2008 First Release NCS PRISM Team October 2008 Change in Screen Captures HSA CTB L HSA NCS Confidential Page 2 of 7 Copyright 2008 National Computer Systems Pte Ltd PRISM User Manual For Internet CT Expedited Safety Report Ver 1 1 Table of Contents L INTRODUCTION iicssssssccsscsscccisscsssessecsisstsecsssstbasssostecssivessoossecdanssiscsscutsessosssceesoeetsoesiaccsossoesdssssonsssessbesesesssesteesssos 4 PURPOSE fd ses s todos TTT vse 4 SCOPB esse eee a ee ae ee RS 4 OVER VIE Wo irasi a a a e a a a e a a aii ees 4 Z FUNCTION sivsscsscsecesisvssesscetsssonssesecnscvsuscodsctecsssecdsccoosevectesseeacsecssvecsosvevessesesssesecossovsuscessedesessevdeseodseteesbbesdocssiustooess 5 2 1 MAPPING OF HSA PIN USERS TO CT PROTOCOL NO 5 2 1 1 TO SU Bic ely 58 aS tees ce ieee See ct Bn evens recedes Lath ga setae Bae ee tara a cate de an coh agua Le Miees SN 5 2 2 FORM OF MAPPING OF HSA PIN USERS TO CT PROTOCOL NO 7 HSA NCS Confidential Page 3 of 7 Copyright 2008 National Computer
4. cation a page will be shown for the applicant to select the company HSA NCS Confidential Page 5 of 7 Copyright 2008 National Computer Systems Pte Ltd PRISM User Manual For Internet CT Expedited Safety Report Ver 1 1 4 Select the specific company and click the Submit button 5 The Terms and Conditions page will be shown The application user is required to read the Terms and Conditions before indicating accept or reject If the Accept button is clicked the user will be able to proceed with the eService If the Cancel button is clicked the page will be re directed to the HSA homepage P Singepore Government Integrity Service Excellence Ratna rea ETT Wasa CROO10 AUTHORIZATION AND AUTHENTICATION MODULE gt TERMS ANO CONDITIONS Terms and Conditions of Use Uptated an of 1010005 By accessing this website and these electronic services you shall be deemed to 4 accept unconditionally and without any amendments the following terms 1 You are responsible for all usage access authenticated by your SingPass and or MSA PIN where applicable Z The information materiais contents contained in the HSA website are protected iby copyright trademark and other forms of proprietary rights All rights title and interest in the same are owned by licensed to or controlled by HSA 3 You shall therefore not reproduce transmit or distribute in any way the information materials contents of the IS
5. f the HSA Pin user or SingPass user with drafter role is mapped to a Clinical Trial Protocol the Clinical Trial Protocol Number will appear in the dropdown list in the Introduction page of CT Expedited Safety Report application form although it was not drafted by him or her previously To Add Mapping 1 Select a Drafter SingPass ID or HSA Pin number Select a Protocol Title Select a Effective Start Date and Effective End Date Click on Add button The new mapping is added to the list at the bottom of page TELUS To Remove Mapping 1 Select a or more existing mapping by clicking the check box 2 Click on Remove button HSA NCS Confidential Page 7 of 7 Copyright 2008 National Computer Systems Pte Ltd
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