Version GENESIS HEALTH SYSTEM. Institutional Review Board (IRB) IRBNet User s Guide

Transcription

1 Version GENESIS HEALTH SYSTEM Institutional Review Board (IRB) IRBNet User s Guide

2 G E N E S I S H E A L T H S Y S T E M I N S T I T U T I O N A L R E V I E W B O A R D IRBNet User s Guide Genesis Health System Research and Grants Administration 1227 E. Rusholme Street Davenport, IA research@genesishealth.com

3 Table of Contents Introduction 1 IRBNet User Registration 1 IRBNet ID Number, Project Vs. Package 2 IRB Submission Process 2 IRB Meetings and Submission Deadlines 3 IRB Forms 3 IRBNet Blue Bar Buttons 4 My Projects 4 Create New Project 4 Project Overview 4 Designer 5 IRB Documents 6 View/Update/Delete 6 Create New Package 6 Unlock a Submitted Package 7 Share this Project 7 Sign this Package 9 Submit this Package 9 Delete this Package 9 Send Project Mail 10 Reviews 10 Project History 10 My Reminders 10 Messages & Alerts 10 IRBNet User Profile 12 User Account Information and Password 12 Changing or Adding an Affiliation 12 Training & Credentials 12 Submission Types 13 New Project 13 Continuing Review/Renewal 14 Modification/Amendment 15 Closure/Final Report 15 Adverse Event 16 Study Suspension 16 FYI, Other Informational Items That You May Need to Report 17 Response/Follow-up to a request from the IRB 18 Accessing IRB-Reviewed Project Documents 19 Documents Generated by the Sponsor or Members of the Research Team 19 Documents Generated by the IRB 19 APPENDIX 1 20 General Naming Conventions 20

4 Introduction Beginning October 14, 2008, (GHS-IRB) began the practice of only accepting submissions electronically through IRBNet. Web Address: T he purpose of this document is to provide guidance for processing IRB submissions electronically through IRBNet. Step-by-step instructions will be given to process each transaction in IRBNet. Additionally, each instruction will include a list of required study documents and GHS-IRB forms to be attached with the submission in IRBNet. These documents are necessary to facilitate the IRB reviewer s knowledge of the study in order to conduct their review. Finally, this document will also provide instructions on how to complete each of the GHS-IRB forms. The following transactions are to be submitted electronically through IRBNet: New Study Continuing Review/Renewal Modification/Amendment Close/Final Report Adverse Events Study Suspensions Informational FYIs Response/Follow-up to IRB requests IRBNet User Registration GHS-IRB requires that all members of the IRB and all Principal Investigators and members of the research team have an IRBNet account. To register as a new user, open IRBNet by navigating your internet browser to Click the New User Registration icon and navigate through the prompts entering providing your information. It is recommended that if you are a Genesis employee, that you use your Genesis . If you are not affiliated with Genesis, use an address that you check frequently. IRBNet will send you notices via prompting you to check IRBNet and notifying you of changes in status to your package. Also when registering, you ll be asked to choose an affiliation. Please select Genesis Health System, Davenport, IA. 1

5 A registration will be sent to the provided. Use this to finalize the registration process. PLEASE NOTE: You must activate your registration from the registration before you may access studies or receive shared access on studies. IRBNet ID Number, Project Versus Package IRBNet will automatically assign a 6-digit ID number to each newly created study. The number following the dash is the Package number for that project. Therefore, a newly created Project will always be 6 digits, dash 1 (i.e ). For each subsequent package, the Project number will not change, just the last digit(s) following the dash. For example, a New Project will be assigned IRBNet ID # A subsequent Amendment is assigned IRBNet # A future AE report or Amendment would be assigned ID # A common problem researchers experience in IRBNet is the creation of multiple-identical projects, or the same project with two different Project IDs. In order to maintain the audit trail within IRBNet, it is important to remember the difference between a New Project and an Active Project. A New Project is precisely what it sounds like; it is a Project that is being submitted to the IRB for the first time. An active project is a project that has been reviewed by the IRB, and now the investigator is looking to submit additional information (Amendment, Continuing Review, AE) to the IRB for review. To submit additional material to the IRB on an Active Project, you will need to Create a New Package. IRB Submission Process Complete the following steps to prepare and submit a package to the GHS-IRB via IRBNet: New Project Active Project Create New Project Project History - Create New Package Share this Project add users Open the New Document Package Save blank IRB form(s) to your computer: Designer select a document from the Document Library and download Fill out the form(s) and save to your computer Upload the completed form(s) and supporting document(s): Designer Add New Document, repeat for each document using the recommended naming rules provided in the appendix of this manual Sign this Package the Principal Investigator must sign the package OR the person who submits the documents on behalf of the PI may sign using Designee Signer Mode Submit this Package submit to GHS-IRB select the appropriate transaction type and, if you wish, provide a brief description in the comments section. This information is ed to the IRB. 2

6 IRB Meetings and Submission Deadlines The fully convened GHS-IRB typically meets every second and last Friday of the month. The GHS-IRB reserves the right to modify or change the schedule at any time, for any reason. To inquire about the IRB Meeting Dates and Submission Deadlines please refer to the calendar on the IRB website, IRB Forms GHS-IRB forms are available on IRBNet for download and use. Individual instructions are provided at the end of each form. Please note these forms will appear in italics throughout this document. To access the instructions for completing the transaction or an individual form, click the blue hyperlink. Listed below is a list of IRB Forms and Submission Types. This area is linked to a later section of this document that explains in detail the requirements for each Submission Type. Submission Type New Project Continuing Review/Renewal Amendment/Modification Closure/Final Report Adverse Event Suspension Form New Study Application Continuing Review Application Study Amendment Application Study Closure Report Adverse Event Report Study Suspension Report 3

7 IRBNet Blue Bar Buttons This section will describe and explain the functionality of each of IRBNet s blue bar buttons that boarder the left side of the IRBNet. My Projects IRBNet will automatically open to the My Projects page once you have logged in. This section allows you to view all studies that you have created or to which you have been shared access. You may sort the list by the Study Title, Status or IRBNet ID. Create New Project A new project is created in IRBNet using the Create New Project menu option. This function only creates new studies. It does not start a new package. To create a new project, follow the instructions in the section entitled New Project. Project Overview After selecting a project from the My Projects page (by clicking the blue project title) the Project Overview page is displayed. This page allows a research team member to get general information regarding the status of the project as well as quick links to other functions within IRBNet. This page lets the research team view information regarding the project, such as: Your share access permissions The status of the current package Shared access permissions of other users Additionally, this page allows you direct access to other administrative menu pages, including the: Designer Share this Project Sign this Package Submit this Package Delete this Package Send Project Mail Reviews Project History 4

8 Designer The Designer is used to access GHS-IRB forms, view attached documents for the current package, add new documents, and access review details for IRB documents. To summarize it very briefly, it s where you load and and store all your study materials that the IRB is going to need to review in order for the project to be reviewed and approved. Via the Designer, IRBNet allows you to add entirely new documents to your package or revise your existing project documents. Add a New Document. 1. Download the document template and related instructions from the document library. 2. Complete downloaded forms or create documents to be submitted. 3. Use the Add New Document button to upload the document into the package. It will not have a revision history (stack of paper icon) at this time since it is new. The Designer can be accessed by any of the following means: 1. Clicking on the Continue icon when creating a new project 2. Clicking on the Designer icon from the Project Administration menu 3. Clicking on the blue Designer hyperlink while previewing your project in Project Overview 4. Clicking on the blue package type hyperlink while previewing the Project History GHS-IRB forms are accessible for download in the Designer section from the GHS-IRB library document drop down list. To use these forms, select the form from the drop down list, complete the form and save the final completed form to your computer. While in the Designer section, follow these instructions for adding the document into the package: 1. Click on the Add New Document icon 2. Select the most relevant Document Type from the scroll down menu (see table Naming Rule to select the appropriate document type for the document to be added 5

9 3. In the area marked Description, the IRB recommends that you follow the naming rules described in Appendix 1 - General Naming Rules 4. Click on the Browse button next to the File. Select your saved document (double click the file or highlight and select Open ) 5. Click the Attach icon. IRB Documents IRBNet sends an automatic once a decision has been made by the GHS-IRB for each individual project package, and when GHS-IRB publishes documents, what IRBNet terms Board Documents, such as approval letters and stamped informed consent. To access the Board Documents, go to the Reviews for the specific project. Underneath a summary of the status for each package submitted for the particular project, entitled Reviews there is an area fittingly called Board Documents. All of the Board Documents issued by the IRB for this project will be found here. Click on either the blue hyperlink text or the document icon to view and print the document(s). Alternatively, IRB documents can be accessed from the Project Overview page for the package. IRBNet automatically defaults to the latest package. You can access the documents by clicking on the blue hyperlink Review Details, if the package has been approved. The overview page also has a blue hyperlink for the previous package. Clicking on the link will bring you to the overview page for that package. See the section Response/Follow-up to a request from the IRB for instructions on replying to modifications requested by the IRB. View/Update/Delete Attached documents can be viewed at any time by any shared user. To view attached forms, click on the view icon of the document from the list of project documents. The update and delete functions can only be conducted by shared users with Full or Write privileges. These functions should occur before submitting a project package. Using these functions after submitting will create a new project package instead of updating the one already submitted. The update function will let you replace the current attached document with a new revised document. IRBNet is not a working system where you can open a file, modify it and save changes. A new document must be uploaded instead. The delete function will completely remove a file from IRBNet. Create New Package Another package may be prepared while a package or multiple packages are pending review. Only an individual with Full access to the project can create a new package. To create a new package: 1. Open the Project History page 2. Click on the Create New Package icon 3. A new package entitled New Document Package will appear in the list 4. Select the new document package 6

10 5. Add documents IRBNet will now default to this package when you re-enter the project. Alternatively, a new package can be created from the Designer when you try to add a new document. Simply accept the warning to create a new package. Unlock a Submitted Package The Office of Research and Grants Administration (RGA) may unlock a package submitted for requested documents, revised documents, or additional documents, as appropriate for the submission. Contact the RGA via to request the project package be unlocked. Be sure to provide an accurate IRBNet ID and package # and a brief reason for the request. Once you have completed making changes as necessary, please notify the RGA that you have completed making by clicking the blue words Mark Revisions Complete which is displayed at the top of the Designer page. Please note: Packages can only be unlocked if no IRB action has occurred and the package is not being reviewed by the IRB at the time of the request. If the package is being reviewed, it may not be unlocked and you will need to create a new package. Please contact the RGA if you have any questions about this process. Share this Project GHS-IRB requires that all members of the research team will need access to the project to read the protocol or documents, document appropriate training, attach documents, sign the project, and/or submit the project for IRB review. There are different levels of permissions available within IRBNet. Only an individual with Full access may submit the project to the IRB. Therefore, it is recommended that for all government or industry sponsored research projects and for some investigator initiated research that two (2) individuals of the project team have Full access. This allows coverage in the evident the research coordinator is unavailable to submit to the IRB. The individual creating a new project will automatically be assigned Full permissions. The definitions used by IRBNet for share access permissions are defined in the blue box on the next page. 7

11 Permissions Full: User may manage all aspects of the project. The user may give and change permissions associated with the project. You may have more than one manager to a project. Write: User may co-edit the project with owner, but not give or change permissions. Any changes a person with "write" access makes to a document using the project designer will automatically transfer across to the owner's copy. Read: User may only access a read-only PDF of the project. All other management features are disabled. Users whose only role is to sign off on project documentation should be granted "Read" access. Users with Read access can view project documentation, communicate with the project team and add their signature. This would typically include advisors, department heads, and other individuals who are required to sign off on the project documentation prior to submission but do not otherwise have a day-to-day role on the project. The following are recommended access permissions for the research team: Principal Investigator (PI) PI s choice, strongly recommend Full Clinical Research Coordinator (RC) Full access Co-Investigators Read access All Other Members of the Research Team Read Access To share access with the research team: 1. Select Share this Project from the menu 2. Click on the blue Share hyperlink 3. Ensure that Genesis Health System, Davenport, IA is highlighted and then click on the Select Organization icon 4. Type in the first letter of the individual s last name, any letter of their full name, or * to list all users and click on the Search icon 5. Place a mark in the appropriate level of access next to the research team member s name (You may mark as many names that are available on that page but will have to re-enter for those names on any proceeding pages) and click on the Save icon 6. Users that have been granted shared access will appear at the bottom of the initial Share this Study page and can also be viewed on the Project Overview page 7. Continue these steps until all members of the research team are given shared access Shared access for research team members can be changed at any time. New staff should be entered as soon as they have met the GHS-IRB requirements for new research staff conducting human subjects research. Departing staff should be removed promptly upon termination. The PI may want to grant another individual Full access in the interim between the departure of one staff and the hiring of a new staff member in order to facilitate the access to IRBNet. The addition/removal of research staff share permissions within IRBNet does not involve review per say by the IRB, although an amendment will need to be submitted adding/removing members of the research team. The PI should ensure 8

12 share permissions are current and accurate to ensure unwarranted access by non-research team individuals. Sign this Package It is the policy of the GHS-IRB that the individual preparing the package sign the package in one of two ways. If the Principal Investigator is preparing the package by herself, then she may sign for herself using Standard Signature Mode. If a Clinical Research Coordinator or another member of the research team is preparing the submission on behalf of the PI, they may sign the package on behalf of the PI by using Designee Signer Mode. To sign a project package: 1. Login into IRBNet 2. Select the project and the corresponding transaction to be signed from the Study Manager screen 3. Click on Sign this Package from the Project Administration menu options 4. In the drop down menu, select the appropriate position within the research team OR use Designee Signer Mode to sign on behalf of the PI. 5. Click the Sign icon A confirmation page showing the date and time stamp of the signature will be displayed and can be viewed at a later time in the Sign this Package page. Submit this Package A research team member with Full share access may submit the transaction to the IRB after the package has been signed. To submit a project package: 1. Click on Submit this Package from the Project Administration menu options or click on the here hyperlink on the Project Overview page 2. Ensure that Anne Arundel Health System, Annapolis, MD is highlighted and then click the Continue icon 3. Select the Submission Type from the drop down menu 4. Give a brief synopsis including whether the submission may qualify for expedited review in the Your Comments section, these comments are ed to the IRB 5. Click on the Submit icon Delete this Package If necessary, you can delete a created package that is pending review by clicking the Delete this Package button. Once a package is deleted the information cannot be retrieved. 9

13 Send Project Mail The Send Mail page allows research team members to communicate with each other through IRBNet regarding a specific project package. The default message requests the recipient to login and view the package. The may be modified accordingly. Within the page, the sender can select any member with share access privilege the by checking the box next to that team member s name. Click the Send icon at the bottom of the to send to the selected team members. Reviews The Reviews Page of IRBNet is divided into two parts. The top part of the page, entitled Reviews, lists the entire project history for each package of the project. The research team can view the package number, submission date, IRB agenda date, type of IRB review, package status and the date that the project expires (needs to be closed or receive continuing review). This information is useful, when looking for information on the second half of the page. The bottom part of the page is called the Board Documents. This section displays all IRB letters and stamped documents that the IRB has approved over the life of the project. To open one of the Board Documents simply the click the blue words pertaining to the document you wish to open. Project History Once a package is submitted, it is locked by IRBNet for GHS-IRB review. New information regarding the project (i.e. another amendment or an SAE) cannot be added without contacting the RGA. Alternatively, a new package can be prepared and submitted via the Create New Package button that appears at the bottom of the Project History page when a current package is not Pending Review. My Reminders My Reminders contains a list of all communications pertaining to any project within you re my Projects queue. An IRBNet personal reminder is automatically activated for you each time you receive a new message or alert. You can also set additional reminders for yourself on the Messages & Alerts pages. Other IRBNet users do not see your personal reminders. You can turn on or silence a personal reminder without affecting other IRBNet users. You can also choose to view recently silenced reminders (within the past 30 days) in addition to your active reminders. Messages & Alerts Messages & Alerts are similar to My Reminders. The main difference is that these messages Aare project specific as opposed to all messages for your entire My Projects list. 10

14 You can set an IRBNet personal reminder on any message or alert. Your personal reminders will automatically appear in your My Reminders list. Other IRBNet users do not see your personal reminders. You can turn on or silence a personal reminder without affecting other IRBNet users. 11

15 IRBNet User Profile At the top of the page, above the picture of a satellite dish pointed upwards, the words User Profile are displayed. The User Profile is where an individual would go in the event they need to change their User Account Information and Password, Change or Add an Affiliation, and add information to their profile regarding Training and Credentials. User Account Information and Password To change your Account Information click the yellow word Edit. The subsequent page will allow you to make name changes to your account and/or change your password. If you wish to change your actual IRBNet username, please contact the RGA to make that change on your behalf. Changing or Adding an Affiliation When a user registers for IRBNet they will initially be assigned to Genesis Health System. There will be no need to change or add registration for most users. However, if a PI was involved with a research project that needed to be approved by another IRB that also used IRBNet they would want to add an affiliation. In this rare circumstance, please contact the RGA or the institution that you wish to affiliate with for further instructions. Training & Credentials Currently, the GHS-IRB requires that all PIs and other members of the research team, with the exception of Sub-Is, complete the NIH Protecting Human Research Participants. The link for this free training is given below: All PIs and other members of the research team, with the exception of Sub-Is, must load their NIH Training Certificate by clicking the Add New Record and then choosing NIH Training or Equivalent Completed. Proof of NIH or equivalent training must be present within IRBNet before full approval can be given to the research project. If an investigator or member of the research team has completed a similar module, the IRB Chair may accept that in lieu of the NIH training if it is deemed equivalent. 12

16 Submission Types New Project Any individual on the research team may create a new study/project. Therefore, a project could be created in IRBNet without your knowledge. If you were not given shared access, you would not be able to view the project in the Study Manager list. GHS-IRB suggests that you contact all other research team members to ensure the project has not yet been created before creating a new project. If a project is accidentally duplicated such that one project has two IRBNet ID numbers, please contact the RGA. To create a new project: 1. Select the Create New Project from the menu. 2. Complete the project information listed in the box below. 3. Once the information is entered, click on the Continue icon. Research Institute Be sure it specifies Genesis Health System, Davenport, IA Title State the full title provided by the sponsor and exactly as it appears on the Protocol Local Principal Investigator Specify the local PI who will be responsible for the conduct of the project under review of the GHS-IRB Keywords Specify keywords that can be used in a search to find this project Sponsor State the individual or organization that is responsible for overseeing the regulatory requirements of the project (i.e. the entity that provides the case report forms or filed the IND); for investigator-initiated studies the PI will be the sponsor; NOTE: this is not the funding source unless regulatory support is provided as defined above Institutional Reference Number An internal code may be used, if required A new project has been created. You will then be directed to add new documents. Follow the instructions for adding project documents in the section entitled Designer. Alternatively, you may logout and continue the new project submission at another time. The following documents must be submitted for initial review and approval by the IRB: Form-New Research Application Full Protocol Proposed Consent form(s) with HIPAA Authorization Investigator s Brochure, if applicable Information given to participants, if applicable Informed Consent, Clean Version for Stamping Informed Consent, Line Numbered Version Any other documents relevant to the review of a new project Once the required documents have been attached, the individual preparing the package should sign the package either on behalf of himself or on behalf of someone else (see Sign 13

17 this Package). Submit the package following the instructions Submit this Package designating the submission type as New Project. Continuing Review/Renewal All active protocols involving human subjects, irrespective of risk level (EXCEPT studies deemed exempt from IRB review) must maintain IRB approval throughout the duration of the project. At the initial review, the IRB will determine the frequency of continuing review. This frequency may change at the determination of the IRB and is typically changed as a result of a change in the risk level or a compliance issue. The frequency of review is based upon the risk level of the protocol as follows: Minimal Risk Every 12 months Greater than Minimal The IRB will determine the review period Although the Investigator will be reminded by the IRB that a continuing review report should be submitted, it is the responsibility of the Investigator to ensure that the report is submitted in a timely manner which allows sufficient time for IRB review, modifications, and approval PRIOR to the protocol s date of expiration. NO research activity should take place after IRB approval has expired, EXCEPT to prevent apparent and immediate harm to the study participant. As the GHS-IRB typically meets twice a month, it may be necessary to submit a continuing review report up to two months in advance of the expiration. This allows adequate time for IRB review, modifications and approval. Minimal risk studies may be reviewed by expedited review procedures; however, the Investigator should still ensure the submission is submitted in a timely manner. To submit a project for continuing review: 1. Access the Designer 2. Click the Add New Document icon 3. Add the following documents, as applicable by following the instructions for adding project documents detailed in the Designer section of this document: The following documents must be submitted for continuing review: Form-Continuing Review Application Proposed Consent form(s), clean copy, if project is actively enrolling DSMB Report, if applicable 4. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Continuing Review. 14

18 Modification/Amendment The Investigator is responsible for promptly submitting protocol amendments to the IRB. Amended procedures may not be implemented until the amendment has been reviewed and approved by the IRB unless the change is necessary reduce or eliminate harm. To process a modification/amendment submission, follow these steps: 1. Access the Designer 2. Click the Add New Document icon 3. Add the following documents, as applicable: The following documents must be submitted for modification/amendment: Form-Study Amendment Application Amended Protocol, if applicable Proposed Consent form(s), Clean and Line Numbered, if applicable Any other documents relevant to the review of a new project, if applicable 4. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Amendment. Closure/Final Report At the conclusion of all data analyses, the PI should submit a closure/final report to the IRB: 1. Access the Study Designer 2. Click the Add New Documents icon 3. Add the following documents, as applicable: The following documents must be submitted for a Closure/Final Report: Form-Study Closure Report Any other documents relevant to the review of a closure, if applicable 4. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Close/Final Report. 15

19 Adverse Event It is the policy of the GHS-IRB that local, serious, unexpected adverse events occurring locally be reported to the IRB within ten days of the research team becoming aware of the event. Additionally, an Unanticipated Problem Involving Risk to Participants or Others could result from a protocol deviation. However, an Unanticipated Problem usually involves the loss of study forms, consents or HIPAA Authorizations or a participant complaint. An Unanticipated Problem also needs to be reported to the IRB using this method. To submit serious adverse events: 1. Access the Designer 2. Click the Add New Document icon 3. Add the following documents, as applicable: The following documents must be submitted for an Adverse Event Report: Form-Adverse Event Report Any other documents relevant to the review of the AE, if applicable 4. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Adverse Event. Study Suspension The PI is responsible for reporting any project suspensions, sponsor related or otherwise, to the GHS-IRB using the Study Suspension Report form. To submit a suspension: 1. Access the Designer 2. Click the Add New Document icon 3. Add the following documents, as applicable: The following documents must be submitted for a Study Suspension Report: Form-Study Suspension Report Any other documents relevant to the review of the Suspension, if applicable 4. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Other. 16

20 FYI, Other Informational Items That You May Need to Report The Investigator is responsible for reporting any new information as it is obtained during the study. Additionally, the investigator might want to report additional items that do not fit the categories outlined above. The IRB refers to these items as FYIs and will acknowledge them and accept them as part of the IRBs record. Note: If the item needs IRB approval, then it must be submitted as an Amendment. To submit FYI items: 1. Access the Designer 2. Click the Add New Document icon 3. Add the following documents, as applicable: The following documents must be submitted for a FYI: Any documents relevant to the acknowledgement of the FYI, if applicable 4. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Other. 17

21 Response/Follow-up to a request from the IRB The IRB may request modification(s) to the protocol or additional details be provided in order to approve a project. The PI and research coordinator will receive an notification from the IRB informing them of the IRB s action and refer them to view the documents in IRBNet. It is the responsibility of the research team to log into IRBNet to view these documents and address any modifications requested. To view the IRB s determination and modification request: 1. Log into IRBNet 2. Select the project (for multiple transactions pending, be sure to open the referenced transaction number based on the last digit which proceeds the project ID number) 3. Select the Study Designer from the administrative menu 4. Click on the blue hyperlink for the Modification Request letter from the IRB When responding to the IRB s modification request, create a new package to maintain the study s chronological history. To respond to the IRB s request: 1. Create a New Package from the Project History page 2. Add the following documents, as applicable: The following documents must be submitted for a Response/Follow-up request: Cover letter detailing the PI s response to each requested modification Revised document(s) and/or form(s)(i.e. updated protocol, modified consent form, if applicable Other documentation, as requested by GHS-IRB 3. Once the required documents have been attached, the individual preparing the package should sign the package either using Standard Signature Mode or Designee Signer Mode (see Sign this Package). Submit the package following the instructions Submit this Package designating the submission type as Response/Follow-up. 18

22 Accessing IRB-Reviewed Project Documents Within IRBNet there are several ways to access different types of documents. Recognizing that there may be other ways to access documents, this is the method that GHS-IRB recommends. The distinction in where the research team will find documents is defined by the following two categories. 1. Documents generated by the sponsor or members of the research team 2. Documents generated by the GHS-IRB Documents Generated by the Sponsor or Members of the Research Team All documents submitted to the GHS-IRB can be accessed by using the Designer page with the most recent package for the project. To open any document submitted, simply click the blue words pertaining to the document you wish to open. Documents Generated by the IRB To access IRB generated documents use the Review Button. On the reviews page you will find all IRB generated letters and stamped informed consents over the project s life cycle. To open any IRB board document, simply click the blue words pertaining to the document you wish to open. 19

23 APPENDIX 1 General Naming Conventions When attaching documents in IRBNet, a description of the document is required. Below is a list of naming conventions that are recommended for use. Use of the following naming conventions will help to facilitate the IRB members recognition of supporting documents for each submission: Document Document Type Description Advertisement Advertisement Flyer/Brochure/etc <date> Form-Study Amendment Amendment/ Form-Amendment <#> Application Modification Amendment information Amendment/ # - Amendment v<#> and/or <date> from the Sponsor Modification Consent form - approved Consent Form Consent approved <date> Consent form Consent Form Consent proposed <MM/YY> proposed/line numbered Form-Continuing Review Continuing Review # - Form-Continuing Review Report <date> Application Report Data Safety & Other DSM Report <date> Monitoring Report HIPAA Authorization HIPAA Consent/ HIPAA <date> Authorization Investigator s Brochure Investigator s Brochure IB/Package Insert - <agent name> or Package Insert Letter Letter Letter <Description> <date> New Study Application Application Form Form-New Study Application Protocol Protocol Protocol v<#> and/or <date> Questionnaire, Handouts Questionnaire <name of questionnaire/handout> <date> Written Response to IRB Letter Response to Modifications Required <date> Requested Modifications Form-Adverse Event Application Form Form-AE, <ptid> <event> Report Form-Waiver of HIPAA HIPAA Waiver Request of Waiver of HIPAA Authorization Authorization Form-Waiver of Consent Waiver Request of Waiver of Informed Consent Informed Consent Form-Waiver of Informed Consent Consent Waiver Request of Waiver of Informed Consent Documentation Documentation Form-Study Closure Closure/Final Report Study Closure Report Report Form-Suspension Report Other Study Suspension Report Other Other <brief description>, <date> 20

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