ELECTRONIC RESEARCH STUDY APPLICATION (ERSA) INITIAL APPLICATION GUIDEBOOK. (Version date 03/03/2006)

Transcription

1 ELECTRONIC RESEARCH STUDY APPLICATION (ERSA) INITIAL APPLICATION GUIDEBOOK (Version date 03/03/2006)

2 Table of Contents ERSA Home Page and Login 3 CRC Desktop 4 Creating a: New Study Application 5 Amendment / Revision 19 Reportable Events (Averse Events, Revised Investigators Brochure, DSMB Reports, Protocol Deviations) 24 Continuing Review 33 Screen Shots Appendix 2

3 ERSA HOME PAGE AND LOGIN The link to the ERSA home page can be found on the IRB intranet site or by typing in the address bar of Internet Explorer. Currently, ERSA is only available through the intranet. The folders to the left of the home page contain useful information, links, and forms templates for you use. Updates of these folders will be ongoing, so visit them often. To login to ERSA, click Login in the top right-hand corner of the screen. (1) The first time you login to ERSA with your assigned user name and password, you will be prompted to change your password. (2) 3

4 CRC DESKTOP From the CRC desktop, you will be able to: Create a new application for A new study Amendments / Revisions Continuing review Reporting AE s, changes in investigator brochures, and protocol deviations Check your inbox for any notifications of study approvals and additional information being requested by the IRB office and ancillary committees (e.g., biosafety, radiation safety, and laser safety). View studies for which you are listed as CRC or study staff and check the status of Study approval Adverse events Continuing Reviews Amendments Your desktop also provides a quick link to the consent forms found in the Forms and Templates folder of the ERSA home page. This allows you easy access to these forms without having to logoff. (3) 4

5 CREATING A NEW STUDY APPLICATION To create a new study, click on the New Study bar on the left-hand side of your desktop page. You will then be presented with the pages of the electronic application. Fields labeled with red text indicate required elements. At any time during the entry of the application, you may stop and come back to the application later. Just click Save in the tool bar between the Back and Continue buttons. Then click Exit. The Basic Study Information page must be completed in order to exit an application. To return to the application from the CRC Desktop: (1) click the Studies tab, (2) click on the title of the study, and (3) click the View Study button in the left margin. Use the Continue button to page through to where you left off. The study pages provide help text in a blue box to the right of the page. Please read the help text if you have any doubt about the information that is being requested. Incomplete information can lead to your application being returned by the IRB. This will slow the assignment to a panel for study review. After completing a page, click the Continue button located at the top or bottom of the page. If you need to go back to a previously completed page, use the Back button within the application. Using the back button of the browser toolbar could result in lost information. (4) 5

6 The Protocol Summary should contain information as found in an abstract. It should be written in lay language and contain information pertaining to the study s purpose, procedures, and methodologies. DO NOT copy and paste from the protocol. It is on this page that you attach the electronic copy of the protocol. If not available electronically, contact the IRB office for assistance. To attach the protocol, click the Add button to open the Submit a Document pop up box. (5) In the box, type Protocol in the Title box with the version date in parentheses. (6) 6

7 Then click the Browse button to locate the appropriate file, and click Open. (7) Then click OK in the Submit a Document pop up box. (8) 7

8 The boxes checked on the Type of Research page will determine which pages of the application will be presented to you. For example, if you select Drugs the Drug Information Page will appear once you click on Continue. (9) Other pages in the application are completed in the same manner. Read the Help text in the blue box for further guidance while completing your application. (10) 8

9 Study Specific Pages The following screens are presented based on your selections on the Type of Research page. Each study is different, therefore, you may not see every page each time you submit a new application. For drug and device studies, the Investigator Brochure, package inserts, and other documents (except the protocol and consent forms) are attached in the FDA and Sponsor Documents section of the drug or device page. Use the same process as used in attaching the protocol document. (11) (12) 9

10 (13) The Diagnostic Radiology / Radiation Safety page will generate an automatic notification to the Radiation Safety Committee. However, it does not constitute an application to this committee for review. The Radiation Safety Committee will contact you for further documentation or application materials as necessary. Continuation of Standard Application Pages When selecting your study population, please keep in mind that the information requested refers to the specific target population. In other words, unless you are specifically recruiting institutionalized individuals as part of your inclusion criteria, you would not check the box for institutionalized individuals. See Help text. (14) 10

11 (15) The Subject Identification and Subject Recruitment pages are self explanatory. See Help text for additional guidance. (16) 11

12 (17) Click Add to open the pop up box and select ethnicity from the drop down box, then type in the number representing the percentage (do not use the % symbol). Click OK. Continue until the total population equals 100. Select the appropriate response regarding request for waiver of informed consent. If a waiver of informed consent is requested, you must provide justification for the request. (18) 12

13 (19) The Informed Consent Process page captures information regarding the informed consent process as well as provides the location to attach your informed consent document(s). Use the same process as used in attaching the protocol document. Based on responses to the risk assessment questions, ERSA will determine eligibility for expedited review. (20) 13

14 (21) At least one of the nine categories must be selected to support expedited review consideration. For definitions of these categories, click the blue Help link found in the upper right corner above the blue help box. When all information is completed, click Finish. Upon clicking finish, you will be taken to the desktop page for the study you just entered. (22) 14

15 (23) Once you have completed your application and are ready to forward it to the PI for review and signature, click the Check Required Elements button to the left. Any incomplete information will be presented to you in red text. You will need to return to the indicated pages for completion. The application can then be forwarded to the PI by clicking the Notify PI button. The PI will automatically receive an in GroupWise, with a link to ERSA, to review and electronically sign the application. NOTE: Only the PI can submit a document to place it into the IRB review process workflow. 15

16 (24) Once the PI has reviewed, signed, and submitted the application, you will receive the following notification: If in the IRB staff review of the application it is found that changes are needed, the IRB staff member will make comments on the application page and return the entire application back to the PI & CRC with comments. You will receive the following notification: (25) 16

17 (26) Once the application is complete and has been reviewed by the IRB staff, the study is assigned to a panel. Once panel assignment and meeting date selection occurs, you will receive the following notification: (27) 17

18 The following is an example of an approval letter generated by ERSA and sent to the PI via GroupWise: (28) 18

19 AMENDMENTS / REVISIONS NOTE: Amendments cannot be submitted for studies that have not been previously reviewed and approved by the IRB. If a study is in process in the IRB office, the process must be completed before you can make any additional changes. In some instances, however, you can request that the study be removed from its current review process and returned for inclusion of the new information to be submitted. To submit a protocol revision, click on the Studies tab on your desktop and then the Approved tab. Find the study needing amendment and click on the study title. To the left of your screen, click on New Amendment. You will be presented with additional pages for completion based on the items checked in question 1.0. (29) 19

20 (30) For consent form changes, enter a brief description of the changes being made. Click the Add button to attach the consent form. If your study already has a consent form attached to it, a link to the form will display in this area, click [edit] next to the form title, and make changes directly in the form. For protocol changes, provide a brief description of the changes in the text box. Later in the amendment form, you will be given the opportunity to return to the main application to attach the revised version of the protocol. (31) 20

21 (32) For advertisement/recruitment material changes, provide a description of the changes in the text box and click Continue. You will be prompted later in the form to return to the main application to attach these materials. Study team members are automatically populated from the original application into the amendment page. Make changes as necessary, either adding or deleting team members. (33) 21

22 (34) The Instructions for Other Changes page provides a link to go to the forms of the main study application for further changes. Click on the blue text link to access the main application. As with the original submission of the application, once changes on a page have been made, click the Continue button on the top or bottom of the page. Once all changes are made, click Finish to return to the amendment application. (35) 22

23 You will then you be presented with the Summary of Changes and Next Steps. This page also provides a link back to the main application pages should you need to go back and make additional changes to the application. (36) Click Finish to complete the Amendment application. Only the PI can submit the amendment application to the IRB office. 23

24 REPORTABLE EVENTS To submit a reportable event, click on the Studies tab on your desktop and then the Approved tab. Find the study for which you are reporting the event and click on the study title. To the left of your screen, click on New Adverse Event. Select the type of event being reported and provide the date of the event and the date the event was reported to the PI. Click Continue. Screens will be presented according to the type of event you select. Internal Serious Adverse Event (37) (38) Select responses as appropriate and click Continue. 24

25 (39) Select the responsible entity(ies) for event monitoring and click Continue. Select the entities that have been notified of the event and attach any related reports (e.g., MedWatch, sponsor reports, DSMB reports) by clicking Add in 2.0. The document pop-up box will appear to attach documentation. (40) 25

26 (41) Indicate whether or not the reported event has changed the overall risk-benefit ratio and the rationale for your response. Click Continue. Complete the responses regarding inclusion of this information in the protocol and/or investigator brochure. Click Continue. (42) 26

27 (43) Complete the responses regarding inclusion of this information in the consent form and whether or not the consent form requires revision as a result of this event. Click Continue. Complete the responses regarding notification to study subjects and/or the need for reconsenting subjects currently enrolled. Click Continue. (44) 27

28 (45) Review the Summary of Event and Next Steps for additional instructions, and click Finish. External Serious Adverse Event Click the Add button in 1.0 to complete the event report. (46) 28

29 (47) Click Ok when complete. If another event is being reported, click add again and complete a second report. Continue this process for each event. To attach safety report documents, click Add in 2.0 and attach document and click Ok to attach the document. Repeat as needed to attach multiple documents. When all documents have been attached, click Continue. (48) 29

30 (49) Review the Summary of Event and Next Steps for additional instructions, and click Finish. Data Safety Monitoring Report (50) Complete the required fields and attach a copy of the report. Click Continue. 30

31 (51) Review the Summary of Event and Next Steps for additional instructions, and click Finish. Protocol Violation (Deviation) Complete questions 1.0 to 5.0 and click Continue. (52) 31

32 (53) Review the Summary of Event and Next Steps for additional instructions, and click Finish. 32

33 CONTINUING REVIEW (CR) NOTE: Continuing Review cannot be submitted for studies that outstanding revisions or reportable events in process with the IRB. If a study is in process in the IRB office, the process must be completed before you can make any additional changes. In some instances, however, you can request that the study be removed from its current review process and returned for inclusion of the new information to be submitted. To submit a continuing review, click on the Studies tab on your desktop and then the Approved tab. Find the study needing continuing review and click on the study title. To the left of your screen, click on New Continuing Review. The study staff information and the protocol summary on the first page will be automatically populated by ERSA. This information is taken from the most recent version of the application in the system. The expiration date is found on the study s approval letter and is entered by clicking on the calendar and selecting the appropriate date. Current protocol activity is a required field. Select the appropriate response, and click Continue. (54) 33

34 (55) Complete all fields as appropriate, referring to help text for guidance / clarification. Remember to scroll down to make sure all fields have been entered. The numbers entered are total numbers for the study, not numbers since the last review. Click Continue. Complete all fields as appropriate, referring to help text for guidance / clarification. Remember to scroll down to make sure all fields have been entered. The numbers entered are reportable events since the last continuing review (or initial review if this is the first CR). Click Continue. (56) 34

35 (57) If a protocol amendment has been implemented but not yet reported to the IRB, the related materials can be attached here for simultaneous review at the time of CR. New/amended protocol, consent documents, and other materials can be attached using the Add button to open the pop-up window. Be sure to give each document an appropriate title (e.g., protocol (with version date), consent form (differentiate if more than one), recruitment brochure, etc.) If any study related publications have resulted since the last review, please attach those documents if available. Click Continue. Review the Summary of Event and Next Steps for additional instructions, and click Finish. (58) 35