REVAPA – Reliable Validation Package Argus
Contents
1. reporter s suffix e g PhD Institution The reporter s institution E Gold ORACLE Partner Field Manda Description tory Department The reporter s institution s department Country The reporter s country State Province The reporter s state or province Postal Code The reporter s zip code Intermediary Double click in field and pick one out of Licensee Local Affiliate Other Regulatory Authority or Sales Rep Sub Section Patient First Last Name or Initials Subject s name or initials Pat ID If case from study enter Patient ID Date of Birth Subject s date of birth Age The patient s derived age at the time on onset Units The derived age units Gender Double click to see list of values Section Literature Reference press Select to pick a reference from the list or enter a new reference the button is only available for literature cases ID An identifier Keywords Keywords separated by commas Journal Full name of the journal Title Full title 3 Check Full Search Like soundex and press Search 4 Verify whether a case in the list of similar cases matches your case If so stop entry Otherwise enter the below fields Field Manda Description tory Sub Section General Seriousness Criteria X Determine whether the case is serious if the case is serious select one or more seriousness criteria Reported Causality The causality as re2. templates only e User manual templates 120 Euro 7 500 e Test script templates 65 Euro 15 000 Time and material e Templates purchased for above fix price with 50 reduction e Customisation and implementation on a time and material basis For more information please contact Hauke Kindler Reliable Lifesciences Consulting Mobile 49 171 786 76 95 Phone 49 2131 450 957 Fax 49 2131 450 958 E mail hauke kindler relico de Address Am Jr ne Meerke 47a 41462 Neuss Germany URL www relico net E Gold ORACLE Partner
3. Print and attach Section Case Search Enter values Criteria Initial Receipt Date lt 12APR10 gt Central Receipt Date lt 14APR10 gt Country FRANCE Report Type double click to select SPONTANEOUS Product Name click select mark record in column Trade Name click select RELICON 10mg Description as Reported vomiting Onset Date Time 10APR10 17 00 Section Case Search Criteria Press Select Press Cancel E Gold ORACLE Partner populated with RELICON and the field Description as Reported is marked with a green check Screen Reporter Lookup pops up with Name Address Rudi Holzapfel screenshot add test goal test case test step date Argus user name name and signature Print and attach screenshot add test goal test case test step date Argus user name name Description of Execution Test Test Data Step Section Case Search Criteria Enter values Last Name Estrider First Last Name or Initials AB Birthdate 12SEP56 Gender Female Check Full Search Soundex Section Case Search Criteria Press Search Close the screen Press Continue Enter values Section Bookin Seriousness Criteria Disability Intervention Required 07 Section Case Search Criteria Test Outcome Expected Results Acceptance criteria Issue No Issue Severity Comment Field Age is populated correctly with 53 Field U
4. RELICO REVAPA Reliable Validation Package Argus Approach Validation according to GCP and to CFR 21 part 11 requires a proper software development life cycle In general the following terms correspond User Acceptance Test Performance Qualification System Test Operational Qualification RELICO assumes that the client will use a software development life cycle as in the schema below RELICO has templates available to support the following tasks system plan user requirements user manual templates 16 commission user acceptance test script templates RELICO can either deliver the templates for a fixed price or can support the whole validation process on the user side on a time and materials basis Overview 9 Retire 1 System Idea J neure Needs Analysis Report 7 Operate Decommission amp Request for Proposal Fix amp Modify Use amp Monitor amp Replace 2 System Plan User 6 Commission What User Require Accept amp Validate to User ments Specification lt __ Requirements Specification adopted from Teri Stokes Drug Informa tion Journal 33 pp 49 61 1999 5 Test r Verify to System Design Specification amp Release 3 Design How System Design Specification 4 Build Program Supplier Configure Vendor Audit E Gold ORACLE Partner The User Requirement Specification has three layers Overall Wor
5. kflow Detail Workflows and User Manual Chapters describing Forms and Reports used to conduct workflow Overall Workflow for Argus Follow up Periodic New a information Vz Report ae arrives we needs to be run Book New Case Identify Data Entry Cases Case Assessment Create Medical Review PSUR or ASR Regulatory Submission CIOMS MedWatch etc E Gold ORACLE Partner Dictionary needs to be updated Do Impact Analysis Perform Recoding Document Recoding Detail Workflow Enter New Case UM Chapter 2 1 Book new case Load document UM Chapter 2 2 Assign document UM Chapter 2 3 to case Send Acknowl Letter UM Chapter 2 4 New case booked E Gold ORACLE Partner User Manual User Requirement Specification Template Example Templates are written in Word for Windows 2 A New Case is Received 2 1 Book New Case To book a new case 1 Select Argus gt Case Actions gt New Case Search Criteria 2 Enter the below fields Field Manda Description tory Sub Section General Initial Receipt Date X The date when the case was received at the sponsor s affiliate Central Receipt Date The date when the case was received at the sponsor s head quarter Country X LOV country where the event occurred either type the first or more letter and tab to pick the country from a code list or enter the country completel
6. nit is populated correctly with Years A screen with an empty list of cases appears The section Bookln appears The BookIn button becomes visible in the bottom Press Add A line is inserted into the section 010 Section Attachements and References Classification double click Report File no column heading press Search button to load file 4 column UAT SAE 001 pdf File Type no column heading 5 column File Attachement iz ik aD 7AN ant Et Press Bookln Press No Gold Partner A windows opens with New Case the text New Case lt New Case gt has been successfully created Do you wish to open the case The Case Actions gt New case screen appears Documen tation Print and attach screenshot add test goal test case test step date Argus user name name and signature Print and attach screenshot add test goal test case test step date Argus user name name and signature Print and attach screenshot add test goal test case test step date Argus user name name and signature Print and attach screenshot add test goal test case test step date Argus user name name and signature Test Test Data Description of Expected Results Test Documen Step Execution Acceptance criteria Outcome tation Issue No Issue Severity Comment 2 l Log off from Argus Logoff successful Pricing Fixed price for the
7. ported by the investigator if the information is available select one value from the list Sub Section Attachments and References press Add to insert a record The derived line number Classification Double click to select a value from the list otherwise leave empty Description The description of the attachement 4 column The file name use the Search button for loading a file into Argus 5 column The type a document can be loaded or referenced by a URL 5 After entering the mandatory fields the BookIn button shows up press BookIn to book the case Either choose to continue with data entry or book further cases Back E Gold ORACLE Partner Test Script Template Example Templates written in Word for Windows Test script corresponds to user manual chapter by that easy tracking of requirements possible The example below has been converted from landscape to portrait because of layout reasons Test Plan Version 1 0 Test objective Enter New Case 1 0 Test goal 2 1 Prerequisites e Test to be performed by role drug_entry Step Login as user Test Data Test 01 DATA_ENTRY Outcome 02 Argus gt Case Actions gt New Test Documen tation Description of Execution Expected Results Acceptance criteria Login successful The screen Initial Case Entry appears Field Generic Name is Issue Severity Issue No Comment
8. y Report Type X LOV the two important entries are clinical trial Compassionate Use Post Marketing Surv and Sponsored Trial and spontaneous all other double click to see the choices or enter the first character s and press tab to see the choices Project ID The field displays the project The field is greyed out for spontaneous cases and becomes enterable for study cases press Select to pick Project ID Study ID and Center ID from the hierarchy Study ID The study see Project ID Center ID The center see Project ID Initial Justification You may enter a justification Product Name X In case of a spontaneous case click select then mark record in column Trade Name in the list of product available for the country if necessary enter additional search criteria click select to pick the value In case of a study case the product is derived Generic Name The derived generic name of the product Description as Reported X Free text coded against MedDRA in case of autocoding a green check is displayed otherwise a red cross manual coding will be done during data entry Onset Date Time Date and time of onset of the adverse event Sub Section Reporter press Select to pick a reporter from the list or enter a new reporter Sal The reporter s salutation e g Dr med First Name The reporter s first name Middle Name The reporter s middle name Last Name The reporter s last name Suffix The
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