Release 2.1. Release Summary Changes for Site Users

Transcription

1 Release 2.1 Release Summary Changes fr Site Users Mdule 1A: Rles & Access Management Explain new site user rles and access rights in accrdance with the R2.1 rle matrix including Head f Facility and Head f Facility Delegate - These rles will nw autmatically be prvided with view access t any new studies added t all facilities r departments t which they are assigned Survey Delegate - An Investigatr can chse t delegate all f their surveys t a specific individual r t delegate each survey when it is received. If the Investigatr delegates each survey, he/she will retain respnsibility fr submitting the survey. If the survey is fully delegated, the PI will receive a cpy f the survey, but cannt edit it. The survey delegate becmes the Survey Recipient and may submit it n behalf f the PI Mdule 2A: User Prfile Key tpic fr enhancing Site User Prfile Training Materials fr R2.1 include: Investigatr access t histrical study infrmatin. Access t site s histrical infrmatin via a link n SIP that takes them t IR Site User's assigned t the investigatr rle will nw have access t 'View My Study Histry' buttn frm their User Prfile. They will be navigated t the Investigatr Registry page where they can view any histrical study infrmatin and assciated metrics available in the IR database Survey Prfile Review Fr Site Feasibility Surveys User and Facility Prfile review will nly be required if ne r mre f the sectins f the prfile are incmplete. If the user prfile is incmplete SIP will generate a task and send it t the PI r the PI s User Prfile Delegate If the Facility/Department Prfile is incmplete a task will be sent t the Primary Facility Prfile Manager. In previus releases this the PI was required t check a bx cnfirming cmpleteness f the prfile View Spnsr Landing Page - All Site Users have the ability t view all Spnsr Landing pages regardless f whether they are wrking n a SIP study fr the spnsr r nt. Mdule 4: Study Enablement Mdule 3: Survey Key tpics fr enhancing Site User Study Enablement training materials fr R2.1 include: Study Site Prfile Key tpics fr enhancing Site User Surveys fr R2.1 include: Types f surveys that are supprted in SIP. Site Feasibility Survey, Satisfactin Survey, Other.

2 Mdule 4: Study Enablement Additinal Lcatins - Site Users can identify additinal lcatins where the study will be cnducted (beynd the primary facility lcatin). These lcatins may be added frm the existing Facility/Department list in SIP r may be manually entered as a single use (unmastered Facility) which cannt be reused n future studies. Replace Primary Facility - Site Users were able t replace a Primary Facility in previus releases, but nw these replacements can have a future date and the histry f the Facility replacement is available in the system. Central IRBs/Central Labs - In additin t adding their wn lcal and central acting as lcal IRBs and lcal labs, sites can nw select frm Central Spnsr-Selected IRBs and Labs set up by the study Spnsr. FDA Frm 1572 Generatin - PIs can generate and esign the 1572 based n the Study Site Prfile. All changes t the Study site prfile are tracked using SIP start and end dates t ensure that Site staff can track when 1572 needs t be generated. Ntificatins are sent t applicable site staff when a 1572 update is required. Site staff can request f change f PI by sending a ntificatin t the Study Team. Study Staff Assignment Site Staff Search - Search was enhanced t allw searching based n staff assigned t all f the PI's Facilities, rather than nly a User search. New Rles - If a Head f Facility and Head f Facility Delegate have been identified fr the Primary Facility/Department, these individuals will autmatically be prvided with view access t the Study Site Prfile Mdule 3: Survey My Surveys Screen Screen has been redesigned fr usability Survey Delegatin Tw types f survey delegatin Permanent survey delegatin vs. single survey delegatin. This eliminates the PI invlvement if the survey is permanently delegated and the delegate becmes the survey recipient. PI can view the survey but cannt update. My Surveys Tab vs. Delegated t me tab The My Surveys tab nw includes surveys that are sent t the Survey Recipient by the Survey Creatr. This includes surveys that are permanently delegated by the PI. The survey delegate becmes the Survey Recipient in this case. If the PI maintains respnsibility fr their surveys but delegates the survey nce it is received, the delegate will receive the survey n the Delegated t Me tab. Survey Statuses There are new survey statuses included in the system. The shw/hide clumns drp-dwn list prvided fr this release allws the user t view additinal details abut the survey. Survey Respnse Study vs. Survey Participatin - If the survey is a Study Feasibility survey, declining the survey is the same as declining the study. Accepting the survey des nt guarantee that the PI is accepted int the study. Fr ther surveys the PI r their delegate must accept r reject the survey nline. Review Prfiles Sectin Survey Delegatin Whether t allw survey delegatin is a spnsrspecific decisin and may nt be available n all surveys. Only users at their Facility will shw up and reference t get ther site users added (add Facility t their User Prfile). Enhanced sectins f the survey and if the PI delegates sectins and questins that the PI must submit. Respnding t Survey Questins Implemented varius types f questins and mandatry vs. ptinal questins, and what it takes t get the green tick mark n a sectin. Implemented the delegated t

3 Mdule 4: Study Enablement Mdule 3: Survey and answered by tags. Original survey recipient can still answer themselves. Review and Submit Print r exprt/save prir t submitting r any time afterward. Only Survey Recipient r PI can d this. Investigatr Referral This is a spnsrspecific decisin and may nt be available n all surveys. Survey Help This is a spnsr-specific decisin and may nt be available n all surveys. Mdule 8A: General Key tpics fr enhancing Site User General Mdule training material fr R2.1 include: Site User landing page has been enhanced fr usability Spnsr landing page has been enhanced fr usability Study News and Links Page has been enhanced fr usability Spnsr News page has been enhanced fr usability Changes fr Spnsr Users Mdule 1: Rles & Access Management Explain new Spnsr User rles and access rights in accrdance with the R 2.1 rle matrix including: Surveys - All spnsr users have the ability t view all surveys and templates and all survey respnse reprts. The ability t create and edit surveys cntinues t nly be available t the Survey Creatr. Survey Creatrs - Survey creatrs nw have the ability t add/remve Ptential Investigatrs frm a Study PI List based n the utcme f a feasibility survey. Spnsr Study Team Members - Any Spnsr User wh is assigned t a Study, has the fllwing capabilities related t Site User Tasks: View site user tasks Remve tasks Send task reminders Mdule 3: Survey Survey Types Cuntry Feasibility Surveys Satisfactin Surveys Other My Surveys Screen Dashbard, Survey Library, and Template Library redesigned fr usability Site User vs. Spnsr User statuses. Wh has access t surveys in which status, and view vs. edit status. Fllwing up with the site if the Facility is remved. Reference t hw t shw/hide clumns if the user wants t view additinal details abut the survey Search fr an existing survey r template - Fr all users Search fr and view a survey respnse fr yur study r ther studies (even histrical studies) - Fr all users Survey Statuses Status Definitins, Site

4 Create ad-hc tasks fr site users Spnsr Admin - Spnsr Admins have the ability t uplad study dcuments, send messages, edit dcument metadata and delete dcuments that they create Spnsr Dcument Admin - Spnsr Dcument Admin nw have the ability t uplad study dcuments Safety Admin, Lcal Safety Officer, General Safety Officer, and Safety Cntact - These are new study level rles that have been added t SIP. These rles have the ability t uplad study dcuments, send messages abut dcuments, edit dcument metadata and delete dcuments (nly till they are in assigned state) Spnsr user nbarding & Spnsr User access management In R2.1, these tw activities serve different functins. Every Spnsr User wh is n-barded t SIP is assigned a primary spnsr rle. This can be any f the 14 regular rles (Type I, Type II, and Type III) after their rles have been selected in SIP via Spnsr user access management functin. Spnsr user nbarding: Intrductin f a new ptin t give access t Spnsr's studies: All Existing & Future: intrduced The platfrm has been upgraded t allw additinal special characters including the apstrphe in Spnsr user names. Spnsr Users can be prvided with a future nbarding, in additin t tday's date. Future nbarding dates can be mdified/cancelled, as needed The platfrm nw allws a single spnsr user t be assigned t multiple rles, including prviding a spnsr with Study Edit and View and Mnitr rles. The General Safety Officer and Mnitrs are studysite level rles. All ther rles prvide study level access. Lcal Safety Officer can be prvided with cuntrylevel access which includes access t all study-sites within the cuntry, Spnsr users can be deactivated frm SIP immediately, r as f future date. If the deactivatin date is set t a future date it can be mdified r cancelled if needed. Remve Site User's Study Access - The current 'site user deactivatin' functin has been renamed fr clarity. The new functin is labeled as 'remve site User vs. Spnsr User Hw t Create a Survey Fr Survey Creatr Only Three methds f creating a survey - Cpy Existing, Use Template, Create New Survey. Including tips n hw t minimize the effrt when creating surveys frm an existing surveys/templates which is nt in SIP. Survey ID assigned n first screen. Parent vs. Child Surveys What they are, when they shuld be used, Study Details Entering the study ID, when required, implicatins f creating a study specific survey withut the ID and what can and cannt be dne withut the study ID Decline Reasns Recmmend which functinality shuld be used when save vs. save as (fr future use) and my default list Survey Summary Reviewing all survey details Implemented Hw t Edit Yur Survey Details after the survey is submitted Design a Survey This feature is available fr Survey Creatr Only Survey Creatin Methd impact n Design Cpy Existing Survey r Use Template Design screen t cntain all cpied questins and respnses Create New Survey Will be blank. Survey Design Cver additinal details t what is n screen fr survey design Creating new sectins and questins/respnses Cpying questins frm existing surveys and templates All functinality including hiding questins/sectins and the reasn t d this Lgic Adding/Updating/Remving Survey Questins If a study team wishes t change a survey after ne r mre recipients have respnded they will need t: Create a Child Survey frm the riginal survey, hide the riginal questins and add the revised questins t the end f the survey. Then resend the survey t the survey recipients wh have nt

5 user's study access', Site User Study Access can be remved immediately r as f a future date. Mdifying Site User Study Access -Site User access can nw be updated in the Study Site Prfile. The 'Request Access Mdificatin' wrkflw fr site staff and PI apprval has been discntinued in R2.1. respnded yet t the survey. Then remve the survey recipients wh received the new survey frm the riginal survey. Fr each change t the survey, the survey creatr will create a Child Survey frm the riginal survey and cmplete the same prcess. Fr each change the survey creatr will have t make all f the changes frm the riginal parent, because a child survey cannt be created frm the new child survey. Therefre, fr the secnd change, the survey creatr must make the changes t the riginal survey plus the additinal changes fr rund 2. When the Survey Creatr r Respnse Manager runs the cnslidated survey respnse reprt they can include the Parent Survey respnses and all child survey respnses. They will need t cnslidate the respnses fr the questins that have changed ver time. Survey Review Functinality Survey reviews are nt required and can be submitted at any time Send surveys t reviewers Fr Survey Creatrs Review and add cmments - Fr Reviewers Run the Survey Reviewer Reprt and use this infrmatin t update the survey design Fr Survey Creatrs Survey Recipients Selected survey recipients can be mved t Study PI list by: Survey Recipients can be selected frm an existing survey r list f ptential investigatrs. Survey recipient list can be upladed and individuals nt registered in SIP can be sent invitatins. Individuals already registered can be added as survey recipients r invited if needed. Survey Recipients can be added t a study as Ptential Investigatrs. Study teams can manage Site Selectin, keeping their Feasibility survey results and ptential investigatr list in sync

6 Describe hw t set Survey Respnse Days and default value Describe the difference between planned and actual survey clse date Hw they behave, surveys cannt be repened, nly use actual survey clse when n mre surveys will be sent. If repen is needed, the study team will need t create a new survey using the clsed survey. Fur methds f identifying survey recipients Implemented new business rules fr reviewing and cmpleting User Prfile and Facility Prfile infrmatin available in SIP Reference Site User materials Manage Study Site Recipient status acrss Survey and Study, and send the survey recipients t a study and vice versa. Identified fr Study first, then survey Identified fr Survey first, then add t PI List Mdule 4: Study Enablement Mdule 5: Training Key tpics fr enhancing Spnsr User Study Wrkspace set up training materials fr R2.1 include: Prvides the ability t set up spnsr and study-specific training curses and curse curriculums Menu updates fr usability View Study Wrkspace - Including an updated screen layut fr usability Create Study Wrkspace Describe new glbal and cuntry level milestnes and functinality Describe hw Central IRB and Central Labs are mastered and what will happen if the data is updated Explain hw t best search fr Central IRBs and Labs in varius lcatins Hw t change/inactivate an IRB/Lab after it has been added and impact n the 1572 hw the change will shw. What the SIP update dates mean. Other business cnsideratins when this happens. (E.g. cntract updates, etc.) Study Cntacts - The training must explain that this is nt linked t the Study Rles set up in SIP. This is manual entry. Prvides Spnsr Training Admin with the ability t manage spnsr and study specific training catalgs, certificate templates, training expiratin, retraining frequency, and training assignments Prvides Spnsr Training Admin with the ability t create curse assignments at Spnsr level, and als by Cmpund, prgram, study, site / rle / user Simplified way t create a Curse Assignment thrugh a Wizard Ability t Grant Credits t site users withut credit apprval prcesses and invite unregistered site users as a part f the prcess Display f ICH Versin n the credit apprval screen Prvides the ability t send training data t Spnsr LMS including MRT training curses Survey/Study PI List Interactin - The

7 Survey and Study Mdules have been aligned t allw site selectin decisins based n Site Feasibility survey results. The definitins f Survey/PI List Statuses will be included in the training. Study Clse-Out and Study Site Clse-Out - The system captures bth a Planned and Actual Study Site Clse date. The planned study clse date will nt clse the study. It is prvided fr site users and spnsrs as an indicatr f timelines. The actual study clse date is entered when the study is clsed, and after this date activity that cannt be perfrmed pst study clse are n lnger available. Safety Ntificatin Start/Stp Dates - Spnsr users are respnsible fr entering the Safety Ntificatin Start and Stp dates in the system. These dates must be manually entered by the Spnsr in rder t start sending safety ntificatins. Safety ntificatins will nly be sent if a spnsr adpts the Safety Ntificatin platfrm which wrks with SIP Mdule 6 & 7: Dcument Exchange and Safety Ntificatins Cmmn Dcuments: - Allwing spnsr users t access all site user prfile, mutually recgnized training certificates and Facility dcuments f site users in ne single place - Enabling SIP Vault Site Exchange integratin t manage study dcuments - Single Sign On frm SIP t Site Exchange frm study dcuments - Spnsr User Safety ntificatin functinality available in SIP fr R 2.1 includes: - Ability t set Safety Letter Start and Stp dates fr each site - Ability t assign site users t safety rles at the study level - Ability t assign Spnsr Users t safety rles at the Admin, Cuntry, Study and Study Site Levels Mdule 8A: General Key tpics fr enhancing Spnsr User General Mdule training material fr R2.1 include: Task Management - Explain that any Spnsr Mdule 8B: Reprts Delivery Failure Reprt - This is a new reprt intrduced in R2.1 t prvide details f unsuccessful delivery

8 User wh is assigned t a Study has the ability t cmplete the fllwing related t Site User Tasks: View site user tasks Remve tasks Send reminders Create ad-hc tasks Study News and Links Creatin Page has been enhanced fr usability including additinal metadata t ensure easier identificatin f news and links items Imprved Search capabilities fr tasks, news and links Mdule 8B: Reprts Key tpics fr enhancing the Site User and Spnsr User Reprts Mdule training material fr R2.1 include: Spnsr User Access Reprt - The search criteria and results have been enhanced t prvide activatin status f Spnsr users at the platfrm and study site levels Describe imprvements in this reprt Task List Reprt - This reprt has been remved in R2.1, as the same infrmatin cannt be exprted directly frm the SIP screen. Study Site Staff Details Reprt - This reprt was previusly called 'Site User Rle Summary' reprt. The search criteria and results have been enhanced t prvide a list f all Study-Site Staff and the start and stp dates fr each assigned Study rle. f s Safety Ntificatins Failure Reprt - This is a new reprt intrduced in R2.1 t prvide details f unsuccessful delivery f s related t safety ntificatins Study Site Staff System Access Reprt - This is a new reprt intrduced in R2.1 t display the system access fr each site staff in a Study. Ptential Investigatr Reprt - The search criteria and results have been enhanced t prvide Ptential Investigatr Selectin and Survey statuses Study Facilities Reprt - This reprt was previusly called 'Study Facility Assciatin Reprt'. The search criteria and results have been enhanced t list all facilities assciated t a Study Survey/Template Details Reprt - The search criteria and results have been enhanced t prvide details abut each survey and template Survey Recipient Registratin Status Reprt- The search criteria and results have been enhanced t prvide platfrm registratin status fr recipients f a survey Update Audit Trail Reprts - All Study and Survey audit trail reprts have been updated based n R2.1 data changes SIP Mdules Impacted M1: Rles and Access Management M2-User Prfile M3: Survey M4: Study Enablement M5: Training M7: Safety Ntificatins M8A: General M8B: Reprts SIP Users Impacted All Spnsr Users

9 All Site Users Deferred Defects Defect Descriptin Functinal Impact Target Justificatin Business Unit updated thrugh the APIs is creating a new ne instead f actually updating it While adding a Spnsr rle in Add Rle screen, the Study Site IDs displayed after Study Selectin are nt in alphabetical rder Clse buttn in view template bx des nt wrk While adding Survey Creatr Rle t spnsr user, all Existing Studies and List f Individual Studies is nt displayed in Study ID drpdwn. Delivery Failure Reprt - Study Id And Study Site Id nt appearing in SIP SIT PUN Extra characters are displayed in Study Shrt Descriptin and Study Lng Descriptin tags when URL is prcessed. Spnsr User is able t select bth the LOVs Srt rder issue. N Functinal impact After pening a training certificate, uer is unable t clse the windw using CLOSE buttn In Spnsr User Access Management, fr Survey Creatr, Admin will nt be able t enable access t individual studies r all existing studies Spnsr user access mgmt. allws Admin t assign a rle fr All Existing & Future Studies. In case a recipient has gt this access, and the t recipient failed, the Delivery Failure reprt will shw Blank/Null instead f All Existing & Future Studies This is an inbund API t get the study details. API return study details alng with descriptin which shws Subscript/Superscript characters R2.1.1 R2.1.1 R2.1.1 API update received after the UAT was clsed, hence mving t next release User is able t see cmplete list f study site IDs, just the rder isn t crrect User can clse using the X buttn f the windw, instead f Clse buttn. SumTtal dependent which Cgnizant wrked ut a slutin fr Cnflicting rles in different mdules needed clarificatin and additinal effrt. This can be crrected in the patch. Due t sme technical challenges and the effrt invlved t fix this it was nt pssible in the current timelines. The impact f subscript and superscript was identified later and nt enugh time t fix in the current release. Create Survey: Subscript and Superscript are nt allwed in Survey Title and Survey Descriptin fields User will nt be able t use super script/sub-script in the fields. Nrmal text will wrk. Future Release This has impact n APIs which was nt knwn earlier. Exprting a Training Certificate t PDF des nt wrk. Pressing OK buttn des nt clse the windw User will have t manually clse the ppped up windw. Future Release This is a SumTtal Dependent issue and will be reslved in cnsultatin with them.

10 Deferred Functinality Summary/ Descriptin Mdule Severity The system shall supprt entry f subscript and superscript characters fr the fllwing fields Training Available Fllwing Training materials have been updated: Prpsed Release General Lw Future Release M1 - Rles and Access Management Site User Online Help - Registratin and Intrductry Sectins Site User Orientatin Guide Spnsr User Online Help - Intrductry Sectins Spnsr User Orientatin Guide Spnsr User Online Help - Admin M2A - User Prfile Site User Online Help - User Prfile Site User Jb Aid (Manage User Prfile) Site User Dem - Create User Prfile Site User Dem - Delegate Cmpletin f User Prfile Site User Dem - Generate CV Spnsr User Online Help - User Prfile Site User FAQs - User Prfile M2B - Facility Prfile Site User Online Help - Facility Prfile Site User Jb Aid (Manage Facility Prfile) Site User Dem - Search fr a Facility Site User Dem - Create Facility/Department Prfile Spnsr User Online Help - Facility Prfile Site User/spnsr User FAQs - Facility Prfile M4- Study Enablement Site User Online Help - Study Wrkspace Site User Jb Aid (Manage Study Wrkspace) Spnsr User Online Help - Study Wrkspace Spnsr User Jb Aid (Manage Ptential Investigatr List) Spnsr User Jb Aid (Manage Study Wrkspace) Spnsr User Dem - Create Study Wrkspace Spnsr User Dem - Create Ptential Investigatr List Spnsr User WBT - Study Wrkspace Study Wrkspace/Study Site FAQs M3- Survey Site User Online Help - Surveys Site User Jb Aid (Manage Surveys) Spnsr User Online Help - Surveys Spnsr User Jb Aid (Surveys: All Spnsr Users) Spnsr User Jb Aid (Survey Creatr) Spnsr User Jb Aid (Survey Reviewer) Spnsr User Jb Aid (Survey Respnse Manager) Spnsr User Dem - Create a Survey Spnsr User Dem - Design a Survey Spnsr User Dem - Survey Review Spnsr User Dem - Review a Survey Respnse Feasibility Surveys FAQs and Spnsr User Surveys FAQs M8- Reprts and General Spnsr User Online Help - Reprts Spnsr User Jb Aid (Reprts) Reprts FAQs

11 Release and earlier