Mo Monthly W thly Webinar ebinar Se Serie ries s March 1-2, - - PowerPoint PPT Presentation

Mo Monthly W thly Webinar ebinar Se Serie ries s

Traditional vs. Aggressive Therapy for Multiple Sclerosis TREATMS

March 1-2, 2018

To Today’s Agenda

• Welcome

11:00-11:05

• Scheduling poll for future webinars

11:05-11:10

• JHM single IRB review process: TREAT-MS

11:10-11:50

• TREAT-MS site reliance status

11:50-11:55

• Closing remarks

11:55-12:00

FU FUTURE WEBINA WEBINAR R SC SCHEDULI EDULING PO POLL LL

• Select the Weekday(s) during which you would be available to attend

an hour-long webinar between 9AM-12PM (Select ALL that apply) Monday AM Tuesday AM Wednesday AM Thursday AM Friday AM

• Select the Weekday(s) during which you would be available to attend

an hour-long webinar between 1PM-5PM (Select ALL that apply) Monday PM Tuesday PM Wednesday PM Thursday PM Friday PM

• Which of the following best describes your role at your site?

PI Site Coordinator Contracts Point of Contact (POC) IRB Point of Contact (POC) Other (MS Specialist, etc.)

JHM Single IRB Review Process: TREAT-MS

Megan Kasimatis Singleton, JD, MBE, CIP Assistant Dean for Human Research Protections Johns Hopkins University School of Medicine IRB Cindy MacInnis, MBA, CCRP Research Services Navigator

To Today’s Feature Presentation

5

JHM Single IRB Review Process: TrEAT-MS

What do Relying Sites Need to Know? Megan Kasimatis Singleton, JD, MBE, CIP

Assistant Dean for Human Research Protections Johns Hopkins University School of Medicine IRB

Cindy MacInnis, MBA, CCRP Research Services Navigator

Agenda

• What are the steps for sIRB review?

– Step 1: Onboarding to the necessary agreements

• SMART IRB Agreement
• Indemnification Addendum
• SMART IRB Exchange Portal Access Agreement

– Step 2: Completion of Local Context Review – Step 3: Site onboarding

6

JHU-Tufts TIC Research Services Navigator Resources

Cindy MacInnis, MBA, CCRP

Research Services Navigator cindy@jhmi.edu 667-208-7370

Ryan Majkowski

Research Assistant rmajkow1@jhmi.edu 443-287-0119

• Single IRB:

– Provide IRB reliance agreements to participating sites – Facilitate agreement execution: provide additional information, aides further discussion with study site IRBs and legal departments – Ensure site managers have approved study documents for distribution – Create study profile in SMART Exchange Portal and facilitate training

• Agreements:

– Facilitates sub agreement drafting with study PI’s institution – Distributes agreements to sites and facilitates negotiation when applicable

STEP 1: ONBOARDING TO THE AGREEMENTS & CEDING REVIEW

8

SMART IRB Reliance Agreement

• In anticipation of the release of the NIH

policy, the National Center for Advancing Translational Sciences [NCATS] funded a multi-institutional collaborative initiative to develop a national IRB reliance agreement [SMART IRB]

– As of September 2016, this agreement is now available: https://smartirb.org/ – FWA-holding Institutions sign on to use the agreement through a joinder process. – Once you are a signatory to SMART, you may use SMART as your reliance agreement for any specific study that also involves institutions that are SMART signatories Key Facts:

• Eliminates the need for study-

specific reliance agreement negotiations

• Institutions may have “addendums”

to cover items not specified in the agreement such as indemnification [JHM IRB does require an indemnification addendum]

• Institutions must have an FWA

[FederalWide Assurance] to sign on

388

signatories

64

CTSA Hubs

How do relying sites cede review?

• Sign onto the SMART IRB agreement via the

joinder process – See www.smartirb.org for joinder resources

• Execute the Letter of Indemnification with JHU

[Will be provided by email]

• Execute the SMART IRB Portal Access

Agreement

– 19 TrEAT-MS sites have signed all 3 agreements! – 10 TrEAT-MS sites have signed 2 of the agreements! – 7 TrEAT-MS sites have signed 1 of the agreements – 9 TrEAT-MS sites have signed no agreements to date

System Overview —Relying Site HRPPs—

A national policy and reliance agreeme ment are necessary, but but no not t suf suffic ficie ient, t, to suppo support rt sI sIRB revie view w

The Reliance Agreeme ment is a 1s is a 1st s t step. ep. IT solutions are needed to support single IRB documentation and communication across institutions.

Imp mpleme menting a National Single IRB Policy

Using the IR Using the IRB Ex Exchang hange e

A web-based portal that helps facilitate the implementation of a single IRB from initiating the reliance process thru study close.

>600

users:

including HRPP/IRB, Coordinating Center, and Study Team staff

>80%

CTSA sites signed on

>150 partner

institutions

50

The IRB Exchange: By The Numb mbers

Studies in progress

29 Trial Innovation Network (TIN) studies 21 Non-TIN studies

Who Who uses the IRB Ex uses the IRB Exchang change? e?

HRPP/IRB Personnel

• Initial Access provided

to 1-2 “Liaisons”

• Liaisons manage who

has access to Exchange for their institution

• Add other HRPP or

IRB staff/members to Exchange

• Remove HRPP or IRB

staff/members from Exchange

Study Teams

• Access provided on a

study-by-study basis by site’s HRPP/IRB users

• Can add other study

team members to Exchange for their site

Coordinating Centers

• Access provided on a

study-by-study basis by site’s HRPP/IRB users

Access is granted after Institutional Official executes the IRB Exchange Portal Access Form

HRPPs track all reliance relationships

Docume ment and track IRB reliance relationships

Email notification to to your HRPP that your site is participating in study

How should I respond to this email? 1. HRPP can open the attachment to view their local PI, and then notify the PI regarding the steps required to initiate reliance. 2. HRPP can login to Exchange and complete local context if they have the submission from their local study team 3. HRPP can ignore the email and wait until their PI submits

Indicating Reliance Step 1: Confirm m Site Engageme ment

If multiple FWAs are engaged for a single study team, let the Reviewing IRB know the other engaged FWAs. The Exchange will capture the cede decision from each FWA. Soon: Relying Site HRPPs will correct/ add FWAs themselves.

AUTOMATIC EMAIL: Relying site study team m emailed about access to Exchange

Indicating Reliance Step 3: Comp mpleting the In Instit itution ional Pr al Profile (IP)

• file (IP)
• If your IP is already complete, you can edit the

information OR confirm it is up to date.

• If you’ve never completed the IP, you will have to

complete it to continue.

In Indic icatin ing R g Relian eliance S ce Step ep 4: Accep 4: Accept t the S e Study-S

• Specific

ecific Re Reliance Plan

AUTOMATIC EMAIL: CIRB and Relying HRPP emailed confirmation of reliance

AUTOMATIC EMAIL: Relying HRPP and study team emailed notification of approval by CIRB

Sites can download all docs in single file

Relying site approval docume ments are available in Ex Exchang hange

Ne Next S Step eps

• Start working on your

Institutional Profile

• Consider who within your

HRPP needs access at your site

• Watch the videos on the

Resource page

• Save the Reviewing and Relying Site Quick Guides
• Begin considering your local requirements when relying on another IRB
• What do you need submitted to your IRB before your PI can rely on another IRB?
• What do you need submitted to your IRB at Continuing Review?
• What do you need submitted to your IRB for study-wide amendments?
• What study-related events do you want reported to your IRB?

Resources: https://starbrite.vanderbilt.edu/rocket/index.php?wg=ws5493

STEP 2: LOCAL CONTEXT REVIEW

26

Single IRB Review ≠ Single Institutional Review

IRB Review Review of investigator training and expertise Ancillary Reviews (Safety, Scientific, COI) Monitoring compliance with local, state laws; HIPAA Institutional Resources Review Grants and Contracts

Responsibilities given to an sIRB

Each Participating Site’s Institution retains responsibility for ancillary and institutional reviews and verifications.

Each Relying Institution will… Communicate to the Reviewing IRB the requirements of any applicable state

• r local laws, regulations, institutional policies,

standards, or other local factors, including local ancillary reviews, relevant to the Research (“Local Considerations”) that would affect the conduct or approval of the Research at the Relying Institution. Such communication may be made through the Reviewing IRB’s designee, as determined by the Participating Institutions in connection with the specific Research. [SMART IRB Agreement]

What is a Relying Organization’s Responsibility?

What types of things do relying sites remain responsible for?

Ø Education/Training/Qualifications. Ensuring that its Research Personnel have adequate education, training, and qualifications to perform the research and safeguard the rights and welfare of participants. This includes ensuring personnel are credentialed to perform the research procedures. Ø Compliance: Ensuring research personnel comply with determinations of the reviewing IRB and all applicable laws/institutional requirements Ø Institutional Reviews: Ensuring all applicable institutional reviews required for the research to be conducted at that site are performed [e.g. radiation safety review, COI review, etc.] Ø Perform local context review: Communicate to the reviewing IRB the requirements of any local laws, ancillary reviews, etc. and provide any required site-specific information for the consent form, where applicable.

JHM sIRB Review Process:

Step 1: Initial Submission

• Convened Review Occurs per normal procedure
• Initial submission will include protocol, template consent, other study

documents

• Board can ask for specific items for local context review

Step 2: Relying Site performs Local Context Review

• JH approved protocol and template consent are distributed to local sites

along with a local context worksheet/survey + site-specific consent template

• Relying sites can communicate any site-specific concerns, locally required

language for the consent, etc.

Step 3: Addition of sites via Change in Research

• Most changes in research will be processed expedited by our sIRB

team [Operations & Compliance Staff]

• If warranted, site additions may be sent to the convened IRB for

review [site-specific factors impact the criteria for approval]

Step 2: How do we get the local context information?

Approved Protocol and Template Consent are “Distributed” Instructions provided for completion of local context form

• Instructions provided by email from site managers
• A study-specific local context questionnaire

tailored for the TrEAT-MS study is attached to the email [word document].

• Includes site-specific “pages” of the consent

[template provided]

31

• Documents supplied via email from the site

managers and available in the Exchange

Step 2: What information are we asking for?

5 parts:

• 1. Basic institutional information [site contacts, FWA #]
• 2. Relying site study team [confirmation of completed local

training; COI management]

• 3. Applicable local requirements [local regulations,

institutional policies, ancillary reviews]

• 4. The conduct of research at the relying site [community

concerns; resources; Board-specified concerns]

• 5. Site Specific Informed Consent Pages [Template

Provided]

5

Step 2: What do we need to know to

• nboard your site?
• Will there be anything happening at your site that is different than

what is described in the approved protocol and consent?

• What site-specific consent language is required for this study related

to state laws/institutional policies?

• Whether any FCOIs been identified specific to this study & provision
• f management plans
• Verification of appropriate training/credentials for site study personnel
• Identification of ancillary reviews that may impact the review of the

sIRB

• Site specific requirements based on state law/institutional policy

relevant to the study [data security, recruitment, community considerations]

5

Understand how “local context review” is

• perationalized at your institution

– Who has the authority at your institution to review and “sign-off”

• n the local context review?

– Is a formal submission to your local IRB required? – What study-specific documents must you submit locally to have the review completed?

JHM IRB Requirements:

• Local context questionnaire must be signed by local site PI AND

institutional representative designated to verify local laws, policies, etc.

• Forms must be complete and site-specific pages must exact consent

language needed in your site’s consent form

Local Context Review: Considerations for Relying Institutions

STEP 3: SITE ONBOARDING

35

JHM sIRB Review Process:

Step 1: Initial Submission

• Convened Review Occurs per normal procedure
• Initial submission will include protocol, template consent, other study

documents

• Board can ask for specific items for local context review

Step 2: Relying Site performs Local Context Review

• JH approved protocol and template consent are distributed to local sites

along with a local context worksheet/survey

• Relying sites can communicate any site-specific concerns, locally required

language for the consent, etc.

Step 3: Addition of sites via Change in Research

• Most changes in research will be processed expedited by our sIRB

team [Operations & Compliance Staff]

• If warranted, site additions may be sent to the convened IRB for

review [site-specific factors impact the criteria for approval]

Step 3: Adding the site

Submit CIR CIR Approved = Relying site activated CIR assigned to expedited agenda; reviewed by:

• Reliance Reviewer
• Compliance Reviewer
• CFS (if applicable)

(1) sIRB review concerns are communicated to study team; requires response. (2) If deferred for convened review, sIRB + IRB committee review concerns are communicated to study team; requires response.

Step 3: Review Process

• Expedited Review Team includes three key

players:

– IRB Reliance Manager: Ensures local context questionnaire is complete – Consent Form Specialist: Ensures site-specific language has been provided for “editable” sections of the consent and builds the consent document [Automated in future state] – Compliance Team Member- Performs a “regulatory review” to identify whether there are areas of concern

• If issues are raised that impact the criteria for approval, the

CIR is assigned to the convened IRB for review – Additional Board members/Board Chair may be involved as needed in the expedited review [e.g. P&T member]

Step 3: Approval

• Once a relying site is approved a site-specific consent form

will be issued [Combines main consent + Site-Specific Pages]

– Note: Your IRB/institution may require receipt of the JHM IRB stamped consent form for use at your site BEFORE your site can be activated locally

• Check with your IRB/organization about the types of items

that will require “local” review during the life of the study?

– Examples:

• Changes that affect local drug dispensation/dosing
• Changes that may trigger a local ancillary review
• Personnel changes/new conflicts

5/11/18 39

Questions/Discussion

Contact Information: Megan Kasimatis Singleton, JD, MBE, CIP Assistant Dean for Human Research Protection and Director of the Human Research Protection Program Johns Hopkins University School of Medicine 1620 McElderry St, Reed Hall 130-B Baltimore, MD 21205 (443) 287-0204 MSingl16@jhmi.edu Janelle Maddox-Regis, MS IRB Reliance Manager Johns Hopkins University School of Medicine 1620 McElderry St, Reed Hall 130-B Baltimore, MD 21205 (410) 502-0376 jmaddox3@jhmi.edu Cindy MacInnis, MBA, CCRP Research Services Navigator JHU-Tufts Trial Innovation Network Johns Hopkins University School of Medicine cindy@jhmi.edu 667-208-7370 Ryan Majkowski Research Assistant JHU-Tufts Trial Innovation Network Johns Hopkins University School of Medicine rmajkow1@jhmi.edu 443-287-0119

Thank you & Questions

References: Slides Provided by Emily Serdoz, Vanderbilt University

Agenda

• Integrated Quality & Risk Management
• Assess Study Complexity
• Review Critical Data & Process
• Brainstorm & Categorize Risks
• Mitigations & Responses
• Key Risk Identifiers (EDC) & “Monitoring Checks”

Coming Soon…

Beginning of next week, the TrEAT-MS website will become active and store all of the webinar recordings

Agenda

• Integrated Quality & Risk Management
• Assess Study Complexity
• Review Critical Data & Process
• Brainstorm & Categorize Risks
• Mitigations & Responses
• Key Risk Identifiers (EDC) & “Monitoring Checks”

TRE TREAT-M

• MS S

Site R e Rel eliance S ce Status

Reliance Agreeme ment Execution Status

Reliance Agreeme ment Execution Status

Th Thank y you

• u f

for

• r

at atte tending to today’s we webinar!

Contact us! IRB & contracts Megan Singleton: msingl16@jhmi.edu Cindy MacInnis: cindy@jhmi.edu Ryan Majkowski: rmajkow1@jhmi.edu Site managers Carolyn Koenig: carolynhkoenig@gmail.com Sarah Lenington: slenington@optonline.net

See you next mo month!