Study Submission Guide - ESTR Support

Transcription

Study Submission Guide
Electronic Submission
Tracking and Reporting
(ESTR)
April 2015
1
Contents
PERSONAL PAGE WORKSPACE .................................................................................................................. 3
CREATING A NEW STUDY .......................................................................................................................... 3
Basic Navigation .................................................................................................................................... 3
What to include in the study SmartForm ............................................................................................. 4
INFORMATION CHECKLIST ........................................................................................................................ 9
EDITING A STUDY .................................................................................................................................... 10
CHECKING FOR ERRORS .......................................................................................................................... 10
Correcting Errors Found Using the Hide/Show Errors option............................................................. 11
SUBMITTING THE STUDY FOR REVIEW ................................................................................................... 11
PROVIDING PI ASSURANCE ..................................................................................................................... 12
AFTER SUBMITTING THE STUDY FOR REVIEW ........................................................................................ 12
Checking the status of your study....................................................................................................... 12
Changing the Primary Contact of the Study........................................................................................ 13
ACCESSING A STUDY ............................................................................................................................... 13
RESPONDING TO CHANGE REQUESTS..................................................................................................... 14
SUBMITTING CONTINUING REVIEWS, MODIFICATIONS, CLOSURES AND REPORTABLE NEW
INFORMATION ........................................................................................................................................ 15
What to include in a Continuing Review or Study Closure ................................................................. 16
What to include in a Modification ...................................................................................................... 17
What to include in Reportable New Information ............................................................................... 19
MORE INFORMATION ............................................................................................................................. 20
CONTACTS ............................................................................................................................................... 20
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PERSONAL PAGE WORKSPACE
After logging in to ESTR with your username and password, you will be directed to your personal page.
Breadcrumb
navigation bar
Click My Inbox to
return to this page
from any other page
Log Off
My Current Actions
& Shortcuts
CREATING A NEW STUDY
Basic Navigation
You can create a new study for IRB review by filling out a series of online forms. The number of forms
you have to fill out may change based on the information you provide. The forms may contain required
information identified by a red asterisk (*), you cannot proceed without providing that information. A
required attachment to the Study Scope form is a Word document that describes the research: either
the Protocol Template or the Not Human Subjects Research Determination Request. Additional
documents are attached to the forms if appropriate, such as recruiting, consenting and debriefing
subject material. It is recommended that these documents be prepared prior to creating the new study;
templates and guidance are available on your IRB website.
To create a new study for review:
• Under My Current Actions, Click Create New Study.
• Fill in the applicable boxes and answer the questions and
attach appropriate documents.
• Click Continue to save the current page and proceed
to the next page.
• When you reach the final page, Click Finish to exit the IRB submission form.
A red asterisk (*) precedes each question that requires an answer; If you cannot answer a required
question at this time see tips in online help. You must provide all required information before you can
submit the study for review.
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What to include in the study SmartForm
The SmartForm is a series of web-pages where you can input specific information about a study. The
following section describes what information should go into each space of the SmartForm.
SmartForm Section: Basic Information
1 Title of study. Enter the complete protocol title. Please avoid use of quotation marks in the study
title. If applicable, include in parentheses the cooperative group, sponsor protocol code/number.
2
Short title. The short title identifies the study throughout the system, such as in your inbox and in an
IRB reviewer's list of submissions to review. This should be 80 characters or less, and should not
contain quotation marks. If left blank, the system will automatically pull in the first 80 characters of
the (long) study title.
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Brief description or abstract. Enter a brief description of the study or the study abstract. This
should be 225 words or less.
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Name of Principal Investigator. Enter the name of the Principal Investigator. For details on who
may be listed in this space, please visit your IRB website.
This field will default to the name of the person completing the form. It may be changed by
selecting clear and typing the name in the space provided (a list will appear with names from which
to select), or you can click the select option to search the list of names. Use the “%” symbol to
replace portions of a name which are unclear or possibly not spelled correctly. This is called a
“wildcard” character.
Select the study's department. Indicate the name of the Principal Investigator or Faculty Sponsor’s
department for this study.
Type the department name in the space provided (a list will appear with options from which to
select), or you can click the select option to search the list of available departments and schools.
Use the “%” symbol to replace portions of a word of which may be unclear or possibly not spelled
correctly. This is called a “wildcard” character.
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For non-faculty Principal Investigators, name of Faculty Sponsor. If the Principal Investigator is not
faculty of Harvard, enter the name of the faculty sponsor. Otherwise, leave this space blank.
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Does the investigator have a financial interest related to this research? Indicate if the Principal
Investigator and/or Faculty Sponsor has a financial interest. For more information regarding what
constitutes a financial interest, please visit your IRB website. If an individual has a financial interest,
complete and attach “FORM: Financial Interest Disclosure Form” to the Supporting Documents page
of the SmartForm.
SmartForm Section: Funding Sources
1 Does this study have funding? Indicate if there are any funding sources for this study. If this is
marked “yes”, please provide further details on this page of the SmartForm. If this is marked “no”,
please ensure no funding is listed on this page of the SmartForm.
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2
Identify funding that has been submitted as a grant proposal to your sponsored programs office.
Find and add all funding sources listed in the Harvard Grants Management Application Suite (GMAS)
that are associated with this study.
Begin typing a piece of the grant PI full name or the funding source (a list will appear with options
from which to select), or you can click the “add” option to search the list of available funding
sources. Use the “%” symbol to replace portions of a word of which may be unclear or possibly not
spelled correctly. This is called a “wildcard” character.
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Identify other non-sponsored funding sources for the study. List all other funding sources. Attach a
complete copy of the funding application or agreement for these listed sources to the Supporting
Documents page of the SmartForm, when applicable, and remove or black-out any salary
information.
SmartForm Section: Study Team Members
The Study Team Members page of the SmartForm should include the name of each person involved in
the design, conduct, or reporting of the research that have either 1) contact with human subjects or 2)
access to identifiable data, directly or indirectly via a coding system or key.
External collaborators must be listed on this page of the SmartForm only in the absence of their local IRB
review.
There is no need to include the name of the PI or Faculty Sponsor on this page, as they are already
identified on the SmartForm: Basic Information page.
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List study team members with an HUID. Click “Add” to include all team members who have an
HUID.
If you would like a person on the study team to access ESTR, and his/her name does not appear in
the search results; this individual must obtain an HUID. Please visit the ESTR support site for
detailed instructions on how to obtain an HUID for use with ESTR.
Each of the individuals listed must complete human research training unless you clearly indicate that
the individual is listed simply for access to this study record (in the Study Team Member details and
via “Add comment” on the submission workspace).
Indicate whether each listed individual has a financial conflict of interest relating to the Human
Research. For more information about what constitutes a conflict, please visit your IRB website. If
an individual has a financial interest, complete “FORM: Financial Interest Disclosure Form” and
attach it to item 2 on this page of the SmartForm.
2
List study team members without an HUID and/or attach other relevant documents. If an
individual’s name does not appear in the search results available, attach a completed “FORM: NonHarvard Study Personnel Form” This form should only list individuals, who were not able to be listed
under item 1 in the Study Team Members section of the SmartForm. Each of the individuals listed
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must complete human research training. Individuals only listed on this form will not have access to
ESTR.
Indicate whether each listed individual has a financial conflict of interest relating to the Human
Research. For more information about what constitutes a conflict, please visit your IRB website. If
an individual has a financial interest, complete “FORM: Financial Interest Disclosure Form” and
attach it here.
SmartForm Section: Study Scope
1 Are there external sites where the Investigator will conduct or oversee the Research? Mark “yes”
here if there are any locations other than Harvard where this project will take place.
SmartForm Sub-Section: External Sites
Provide information for each external site along with the external sites’ approval notice. If local
approval is not available at the time of submission, a copy must be submitted to the IRB prior to
implementing any study procedures at external site(s).
To request that a non-Harvard Catalyst institution rely on a Harvard IRB, attach “FORM: IRB
Authorization Request.”
To request that a Harvard Catalyst institution rely on a Harvard IRB, visit this link. You will be
expected to login using your eCommons or HUID and PIN.
2
Does the study involve the use of a drug in one or more persons other than use of an approved
drug in the course of medical practice? Indicate if drugs, biologics, foods or dietary supplements are
used in the Human Research.
SmartForm Sub-Section: Drugs
Identify all drugs, biologics, foods and dietary supplements (approved and unapproved) being used
in the Human Research. For each, indicate whether it has an IND number and for those that do,
ensure that the application includes one of the following: (a) sponsor protocol with the IND number;
(b) communication from the sponsor with the IND number; or (c) communication from the FDA with
the IND number. Additionally attach the following items:
•
•
•
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Investigator Brochure for each investigational drug involved in the Human Research.
Current Package Insert. Submit for each marketed drug involved in the Human Research.
Validation of IND#, e.g. FDA Approval letter or Sponsor Protocol
Does the study involve: (1) The use of a device in one or more persons that evaluates the safety or
effectiveness of that device, or (2) Data regarding the use of a device on human specimens?
Indicate if a device is used in the Human Research.
SmartForm Sub-Section: Devices
Identify all devices being evaluated for safety or effectiveness or as a comparator (approved and
unapproved). For each, indicate whether it has an IDE number and for those that do, ensure that
the application includes one of the following: (a) sponsor protocol with the IDE number; (b)
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communication from the sponsor with the IDE number; or (c) communication from the FDA with the
IDE number. Indicate whether the device is being submitted under the “Abbreviated IDE
requirements” in 21 CFR 812.2(b). Additionally attach the following items:
•
•
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Current Product Information, e.g., Device Manual. Submit for each investigational device
involved in the Human Research.
Validation of IND# or IDE#, e.g. FDA Approval letter or Sponsor Protocol
Attach the Research Protocol or Not Human Subjects Research Determination Request Form.
Select and use the templates provided on the SmartForm or on your IRB website that is appropriate
for your project and the IRB to which you are submitting. Attach a copy of the completed protocol
template, or if this application represents a request for a “Not Human Subjects Research
determination”, attach “FORM: Not Human Subjects Research Determination.” Of note, a research
protocol is required for Exemption Requests. Be sure to name the file in a manner that identifies it
as your protocol.
SmartForm Section: Consent, Assent and HIPAA Authorization Materials
1 Document Upload. Use the templates appropriate to your IRB to create and attach the following
items. Visit your IRB website for additional instructions regarding how to create consent materials:
• Consent, Assent Forms, or Scripts including HIPAA Authorization Forms (as applicable).
Consent/assent documents must include version date and/or version number. If any consent
materials will be translated, attach “FORM: Translation Attestation” to the Supporting
Documents section of the SmartForm which appears later in the submission process.
• DHHS-approved sample consent document. Consent documents must include version date
and/or version number. If consent materials will be translated, submit “FORM: Translation
Attestation.”
SmartForm Section: Supporting Documents
Attach supporting files, naming them as you want them to appear in the approval letter:
•
•
•
•
•
Ancillary Approvals/Permissions. Submit approval letters or permissions from any additional
office or organization reviewing this project (for example, a copy of the determination letter
from Harvard University IT review). If unavailable at the time of submission, plan to submit a
copy to the IRB prior to implementing any study procedures.
Data use agreements or other Agreements. Submit copies of any documents authorizing the
use of data, or other contracts or agreements associated with the study.
Debriefing Materials. If any of these materials will be translated, also submit a Translation
Attestation Form.
External Sites’ Approval Notice. If not attached earlier in the SmartForm Section: Study Scope,
submit an approval notice from each external site identified in the SmartForm. If unavailable at
the time of submission, plan to submit a copy to the IRB prior to implementing any study
procedures at the external site(s).
Federal Department Requirements Checklists. Attach any required checklist associated with
certain kinds of Federal funding (such as DOD, DOJ or EPA).
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•
•
•
•
•
•
•
•
•
•
•
Financial Interest Disclosure Form. Submit this form for any Principal Investigator or Faculty
Sponsor which self-identifies a financial conflict of interest related to the research on the
SmartForm: Basic Information page. Forms for any other team members which self-identify a
financial conflict of interest should be attached to the SmartForm: Study Team Members page.
Foreign Language Documents. Submit all translated study materials.
Funding Source Attachments. If not associated with GMAS and as applicable, submit a complete
copy of the grant applications, subcontract, and/or any funding agreements regardless of
funding source.
Individual Investigator Agreement (IIA). When a non-Harvard collaborator will be covered
under the Harvard IRB review and this person is not affiliated with another institution, submit
this form here or attached a completed copy to the SmartForm: Study Team Members page.
IRB Authorization Agreement (IAA) Request. When multiple institutions are engaged in the
Human Research, submit this form allowing an investigator to designate Harvard as the
Reviewing Institution (responsible for IRB review) or Relying Institution only when such
agreements are with non-Harvard Catalyst institutions. To request such an agreement with a
Harvard Catalyst institution, visit this link.
PI’s Current CV (ICH-GCP E6 Only). Submit a copy of the Principal Investigator’s current
(signed/dated) CV only when required by sponsor to follow the “International Council on
Harmonisation – Good Clinical Practice E6.”
Radiation Safety Form. If the Human Research involves the use of approved or unapproved
diagnostic or therapeutic radiation outside routine clinical practice, complete and submit
“FORM: Radiation Safety.”
Recruitment Materials/Advertisements. Each recruitment document/script must include
version date and/or version number. Guidance on what is appropriate to include and exclude
within an advertisement can be found in “WORKSHEET: Advertisements and Payments.”
Advertising material must include version date and/or version number. If any of materials will be
translated, submit “FORM: Translation Attestation.”
Sponsor Protocol including DHHS-approved protocol. Submit the sponsor protocol, if
applicable.
Study Instruments/Tools. Including all data collection instruments, questionnaires, surveys,
focus group discussion guides, or interview guides. Do not include Case Report Forms. Study
documents must include version date and/or version number. If any materials will be translated,
submit “FORM: Translation Attestation.”
Translation Attestation Form. Submit this form at the time of initial application if any study
documents will be administered in languages other than English. Obtain the PI and translator’s
signature. This form must also be submitted as part of a study modification when requesting
approval for the use of new study documents that will be translated. Submit the locallyapproved, translated documents to the IRB when they become available.
Upon selecting continue from this page, the browser will direct to the last page of the SmartForm where
you will have the opportunity to select “finish” to return to the submission workspace.
Important!
Clicking Finish does not send the study for review.
A member of the study team may click Submit (marked with a red arrow in the submission workspace), but the 8
principal investigator must click Submit and Provide Assurance (marked with a red arrow in the submission
workspace), for the submission to proceed on for the next state of review.
INFORMATION CHECKLIST
There are several forms with places to attach documents during the submission process.
When attaching a file, give the file a meaningful name and name it as you want it to appear on the IRB
approval letter. Attach the information below to the identified location (if applicable to your study).
Funding Information: Funding Sources page, with each source
• Grant related attachments should be included
on the “Supporting Documents” page.
Study Team Members: Page to add study team members, with each staff member
• Study Personnel Form, listing team members
• Individual Investigator Agreement for nonwho do not have an HUID and cannot be listed
Harvard Collaborators without an institutional
with item 1
affiliation.
• Completed Financial Interest Disclosure Forms
External Sites: External site page to add other institutions engaged in the research
• Site approvals
Drug Details: Drugs page, with each drug, or on main Drugs page if not specific to one drug
• Package insert
• Verification of each IND number
o Sponsor protocol with the IND
• Investigator brochure
number
o Communication from the FDA or
sponsor with the IND number
Devices Details: Devices page, with each device, or on main Devices page if not specific to one
Device
• Product labeling/device instructions
• Verification of each IDE or HDE number (one of
these):
• Investigator brochure
o Sponsor protocol with the IDE / HDE
number
o Communication from the FDA or
sponsor with the IDE /HDE number
Protocol definition: Study Scope page
• Research protocol OR Not Human Subjects
Research Determination Request Form
Consent: Consent, Assent and HIPAA Authorization Materials page
• Consent documents
o HHS-approved consent forms
o For non-written consent, a script of
the information provided orally to the
subjects
All other relevant information: Supporting Documents page
• Conflict of Interest Committee’s determination
• Debriefing Materials Translation Attestation
for each financial interest related to the
Form
research
• Completed checklist of meeting Department of
Energy requirements
• Material to be seen or heard by the subjects
• Recruitment Materials
• Grant Materials (if the grant is not included in
GMAS)
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EDITING A STUDY
You can make changes to a study until you submit it for IRB review. You can also make changes if the IRB
requests clarification or modification (except during committee review).
To edit a study:
• Find the study in My Inbox.
• Click the name of the study.
• Click Edit Study on the left (under My Current Actions).
• Make necessary changes, including uploading revised
versions of documents.
• Exit the study.
You can exit by:
• Click the Exit link. If prompted to save study, click Yes.
•
Click Continue through to the final page, and click Finish.
CHECKING FOR ERRORS
Before you submit a study it is important to check that you have all the necessary information, this will
help reduce the turnaround time for your submission.
You can check for errors using the following:
• Visually inspecting the forms to see what you may have overlooked particularly:
o Documents that should be attached.
o Questions which are not required but still relevant to your study.
• Automatic system error checking identifies required information that has not been provided.
The red asterisk (*) identifies questions that require information to be provided. However the
system cannot catch questions that may be relevant yet not marked as required.
• Using the Hide/Show Errors option. The system performs an error check to highlight errors in
an error/warning pane at the bottom of the screen.
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Correcting Errors Found Using the Hide/Show Errors option
• Click the link under the Jump To column header to go to the form containing the error.
• Click Continue to identify the specific errors on the form.
• Correct the errors.
• Click Save.
• Click Refresh in the Error/Warning Messages pane to update the errors.
• Continue correcting the errors until no errors are listed.
SUBMITTING THE STUDY FOR REVIEW
After filling out all the forms correctly and attaching relevant files, the PI must submit the study for IRB
review.
Important! Any member of the study team may complete these steps, but only the Principal
Investigator can submit and provide assurance (see “Providing PI Assurance”).
To submit the study:
• Log in to the system.
• Click on My Inbox.
• Click on the name of the study to open it.
• Click Submit (marked with a red arrow) in the My Current Actions
list on the left.
If any errors or warnings are shown, follow steps described in Correcting Errors Found Using the
Hide/Show Errors option above.
•
•
Click OK to agree and validate your submission.
Click Submit.
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PROVIDING PI ASSURANCE
PI Assurance is a required step before a study can be reviewed and/or issued an IRB approval or
exemption determination. If the study has a Faculty Sponsor, the Faculty Sponsor must provide
assurance before the study can be issued an approval or exemption determination.
To provide assurance on a study:
• Open the study.
• Click Submit and Provide Assurance.
• Agree to the statements in the popup window.
• Click OK.
• Log entry is recorded in the study History log to verify PI or
Faculty Sponsor endorsement as shown below.
AFTER SUBMITTING THE STUDY FOR REVIEW
After you submit your study for review a series of activities follow that may necessitate further action
from you, such as requests for clarification or modification to your study. Whenever you need to act,
you receive an email notification, and the study appears in My Inbox when you log into the IRB system.
Make sure the appropriate person is listed as the Primary Contact to receive the email and see the
study in My Inbox, the PI always receives these notifications. By default, the person who created
the study is the primary contact.
Checking the status of your study
When you open the study you can see its status using the process-flow diagram.
You can also open your study by clicking on it from any of the following tabs listed on Submissions page,
depending on its current state:
• All Submissions
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•
•
•
In-Review
Active
Archived
Changing the Primary Contact of the Study
You can change the primary contact of the study at any time. This person will receive communication
from the IRB about the study.
To change the primary contact:
• Open the study by clicking the study’s name.
• Click Assign Primary Contact from the My Current Actions on the left.
o A popup appears
• Click Clear to remove current contact.
• Type in the name of the new contact and select name from the filtered list of options.
• Click OK.
ACCESSING A STUDY
Access to a study is dependent upon your role in the IRB system as well as specific to your role on a
particular study. The actions you are required to perform on a study are also specific to your role on the
study.
Check this list…
My Inbox
All Submissions
In-Review
Active
Archived
New Information
Reports
External IRB
For…
Studies assigned to you for action,
such as studies you are:
• Preparing to submit
• Assigned to review
All studies, modifications, continuing
reviews, and reportable new
information (RNI) entered into the
system that you have permissions to
view
Studies that the IRB has not
reviewed or for which it has not
issued communication
Studies approved or given an
exemption determination by the IRB
and are currently in progress
Submissions which are closed or
withdrawn
Reportable New Information
possibly related to one or more
studies
Studies where the Harvard IRB is
relying on the review of another IRB.
How to find this list.
Click the My Inbox link at the upper-right.
Click the Submissions link on the left and
select All Submissions tab. Use the Filter by
option to filter through the listed studies.
select In-Review tab.
select Active tab.
select the Archived tab.
select Reportable New Information tab.
select External IRB tab.
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RESPONDING TO CHANGE REQUESTS
During the review process the IRB may request clarification on the study content as well as require
changes in the study before research can begin.
In both cases the PI and the study’s primary contact will receive email notification and the study will
appear in My Inbox.
To respond to change requests:
• From My Inbox, click on the name of the study to open it.
• Locate the change requests in the History tab.
o Under the Activity column, Click on the Clarification Requested to open the details of
the clarification request.
•
•
•
Edit the study to make requested changes.
o Update all aspects of the study, including document attachments within the SmartForm.
o If clarification was requested, and you cannot use the Edit Study option, respond to the
reviewer by commenting in the Submit Changes activity form.
Click Submit Changes to return the study to the reviewers.
o The Submit Changes form gives you space to type a description of the changes made in
response to the requests. You can also attach a file, but, do not attach files to the
Submit Changes form that should be attached while editing the study (such as a
protocol, consent form, etc.).
Click OK.
The study returns to the review process.
Note: When the IRB requests clarification or modification, study staff (including the PI) may edit the
study in order to make the changes. Note that once completed, a member of the study team must
‘submit changes’ back to the IRB for review to proceed.
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SUBMITTING CONTINUING REVIEWS, MODIFICATIONS, CLOSURES AND
REPORTABLE NEW INFORMATION
To Submit …
Continuing Review
Updates for an
active study
Request for Study
Closure
Start here…
From the Active tab,
click the study name.
Click this button
Notes
The first form prompts you to
identify the type of information to
submit. You can separately submit
a continuing review or a
modification. A request for study
closing is made through the CR
form.
Continuing review and
modification submissions are
managed separately from each
submission workspace.
submit.
A request for study closure is
made by selecting the “continuing
review” radio button.
Modifications for
active study
Reportable New
Information (such
as an adverse
event)
Within the study
workspace, click the
“Report New
Information” button.
submit. You can separately submit
a modification or continuing
review.
Continuing review and
modification submissions are
managed separately from each
submission workspace.
Report new information as soon as
you become aware of it. The form
identifies the type of information
that you must report.
For information affecting
a not-yet- submitted
study OR to submit a
report accessible to you
and the IRB (not visible
to your study team
members) click the
“Report New
Information” button in
My Inbox.
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To Submit …
Updates on a study
that have not been
submitted to the
IRB for review.
Start here…
Open the study by
clicking on it.
Click this button
Notes
See EDITING A STUDY
What to include in a Continuing Review or Study Closure
The Continuing Review SmartForm is two web-pages where you can input specific information about the
status of a study. This form should be completed to request study closure. The following section
describes what information should go into each space of the Continuing Review SmartForm.
SmartForm Section: Modification or Continuing Review/Study Closure
What is the Purpose of the submission? Select the radio button beside “Continuing Review” to proceed
with this type of submission. You should also select this option when seeking to close a study. Only one
of the options, continuing review or modification can be selected within one form. See “What to include
in a modification” for information about separately submitting a modification.
SmartForm Section: Continuing Review/Study Closure Information
1 Specify Enrollment Totals. In the spaces provided indicate the number of participants enrolled, or,
for secondary analysis studies, the number of individuals whose data, documents, records, and/or
specimens were utilized. Enrollment totals should reflect the numbers both since initial review and
the last continuing review. Entering a zero would only be applicable when no participants have been
enrolled, or no data have been utilized, to date.
2
Specify vulnerable population enrollment totals at Investigator’s sites since study activation. In
the spaces provided indicate the number of participants who are considered part of the listed
vulnerable populations. The approval letter for the study (or recent modification including one or
more of these populations) will indicate if the IRB has reviewed the study to include specific
vulnerable populations. If a member of a vulnerable population was targeted and enrolled for
participation, but was not previously identified in the research protocol, please contact your IRB
Contact to identify if additional information is needed for review. If none, a zero must be placed in
the spaces required. Of note, if students/employees were not identified as a vulnerable population
in your approval letter, you should place a zero in this box even if your study enrolled students
and/or employees.
3
Research milestones. Select the features of the project that apply to the current status. This
information is used to assess mode of review and possible study closure. If the project is a
secondary analysis study and is ongoing, only the ‘Collection of private identifiable information is
complete’ box should be checked. Once data collection for a secondary analysis study is complete,
the ‘The research is permanently closed to enrollment’ and ‘Collection of private identifiable
information is complete’ boxes should be checked. If no milestones have been reached, this
question may be left blank. A study may be closed when all subjects have completed participation
(including all follow-up activities) and data analysis is complete or data analysis continues only on
16
data that are no longer in any way identifiable (which includes access to a keycode linking
participants’ identities to their data). In addition, a study should be closed when your Harvard
affiliation ends.
4
If research is permanently closed to enrollment, indicate the date of the last subject enrolled.
Indicate the date of last enrollment or the date all data were received for analysis (and no new data
will be obtained).
5
Do any investigators or research staff have a financial interest related to the research that was not
described in a previous application? Indicate if any member of the approved study team has new
disclosures to provide. If this is marked yes, attach a completed “FORM: Financial Interest
Disclosure” for each new disclosure to question 7 of this form.
6
Answer the following questions referring to all sites involved in the research. Indicate ‘yes’ or ‘no’
to each of the items in this section. Follow the instructions beside each question and if more
information is required, provide it in the manner noted on the SmartForm.
7
Attach a brief summary of the study progress. A study progress report must be attached to this
section. Indicate in the study progress report if you are requesting the closure of the study.
Additionally attach any items relevant to the responses in question 6 of this form, and any new
positive disclosures noted in question 5 of this form.
Select “continue” to save this form and navigate to the submission workspace. The form may be
updated by selecting “Edit Submission” at any time in the submission workspace.
Note: Documents attached to the Continuing Review SmartForm will not appear via the submission
workspace (there is no tab for documents). To access documents attached to the Continuing
Review, use the “view submission” or “printer version” buttons on the left of the workspace.
Important!
Once the form is complete, the PI must complete the Submit activity (marked with a red arrow in the submission
workspace) to confirm assurance and move the submission on for IRB review.
Only the PI can complete this activity on a follow on submission, no other members of the study team will have
the option available.
Note that the IRB cannot begin review of the submission until the PI completes the Submit activity.
What to include in a Modification
The Modification SmartForm contains two web-pages where you indicate specific changes, then proceed
to the current SmartForm for the study to make the changes requested. The following section describes
what information should go into each space of the Modification SmartForm.
17
SmartForm Section: Modification or Continuing Review/Study Closure
What is the Purpose of the submission? Select the radio button beside “Modification” to proceed with
this type of submission. Only one of the options, continuing review or modification can be selected
within one form. See “What to include in a continuing review” for information about separately
submitting a continuing review.
Modification Scope This option will appear once the purpose of the submission is identified as a
modification. Select one or both options to request a change to the approved study.
Study team members-If selected, subsequent pages will display only the “study team
members” page of the main study SmartForm for requested changes.
Other parts of the study If selected, subsequent pages will display all pages of the main
study SmartForm EXCEPT the “study team members” page.
Only one of each type of modification may be open in pre-submission or for review at one time.
If a modification of a specified type is currently open and not yet approved, it will appear on the
page with a link to that submission workspace.
Select “continue” to save this form and navigate to the submission workspace. The form may be
updated by selecting “Edit Study” at any time in the submission workspace.
Modification Information
1 Study enrollment status. Select the features that apply to the current status of the project. If no
status applies, this question may be left blank.
2
Notification of Subjects. Select the features that apply to the proposed modification. If none apply
(e.g., the changes do not involve information that should be provided to current or former
participants because it may affect their willingness to continue participation), this question may be
left blank.
3
In your opinion, does the proposed modification(s) alter the risk benefit ratio of the protocol?
Indicate yes or no and provide some rationale in the space provided for question 4 of this form.
4
Describe the proposed modification(s) and the rationale behind the changes. Describe the planned
changes in the space provided. If the purpose of the modification is to fill information into the
system for a study that was active when ESTR was implemented by your IRB (also referred to as a
‘migrated study’), clearly indicate what information is being included which is currently approved
(remains completely unchanged) and clearly indicate any changes which should be reviewed with
the request.
Select “continue” to save this form and navigate to appropriate page(s) of the SmartForm to make any
needed changes. When making changes to the study SmartForm, please note the following:
18
•
•
•
•
More information about what to include within the study Smartform, can be found in the
section of this document: “What to include in the study SmartForm.”
Make changes to previously approved documents via the “update” button beside the currently
included attachment (do not use delete unless you intend to remove the whole document from
the study).
If the modification is associated with a migrated study, required fields of the SmartForm must
be completed before the modification may be submitted (even if you did not yet plan to
completely fill in the SmartForm with all the information about the study).
You can navigate directly to the page(s) of the SmartForm which are associated with the change
by using the “jump to” menu. However, remember to select “Save” on each revised page
BEFORE navigating away.
By selecting “Exit” you will return to the modification submission workspace. The form may be updated
by selecting “Edit Submission” at any time in the submission workspace.
Important!
Once the form is complete, the PI must complete the Submit activity (marked with a red arrow in the submission
workspace) to confirm assurance and move the submission on for IRB review.
Only the PI can complete this activity on a follow on submission, no other members of the study team will have
the option available.
Note that the IRB cannot begin review of the submission until the PI completes the Submit activity.
What to include in Reportable New Information
The Reportable New Information SmartForm is one to two web-pages where you indicate information
required for IRB review.
1
Date you became aware of the information. Indicate the date the information became available to
report. Please review requirements associated with timing for reports on your IRB website. This
cannot be noted as a date in the future.
2
Identify the categories that represent the new information. Select the categories (one or more)
associated with this report.
3
Briefly describe the new information. Provide details about the associated report that is attached
in question 6. Please include relevant information and if the event is ongoing or resolved.
4
In the PI’s opinion. Indicate the information as specified on the form. If any items are marked ‘yes’
a separate modification must be submitted. See “What to include in a Modification” for information
regarding how to submit a modification.
5
Related Study. If the report is associated with a study, it must be indicated here. If the submission
includes a report about the activities of a member of the study team and should remain confidential
19
between the reporter and IRB, do not indicate the associated study in this space.
6
Attach files containing supporting information. Attach any related files, or reference materials in
the space provided. Do not attach a modification request. A modification must be submitted
separately via ESTR.
By selecting “Exit” you will return to the new information submission workspace. The form may be
updated by selecting “Edit RNI” at any time in the submission workspace.
Important!
The person who initiated the submission may complete the Submit activity
(marked with a red arrow in the submission workspace) to move the submission on for IRB review.
If the submission is associated with a study under question 5 of this form, once complete, any member
of the approved study team may complete the “Submit” activity to move the submission on for IRB
review.
MORE INFORMATION
You can find more information while you work through submitting your study.
To find…
Look for…
and click.
More information about a question or
The question icon next to the
form title within the form
question or form title.
Online help with job aids and additional
Click Help Center in the Shortcuts
information. Online help contains more
menu on the left.
information for all users.
Document templates, checklists, and IRB
procedures and guidance.
Click Library in the Shortcuts menu
on the left.
CONTACTS
For additional answers to your questions, feel free to use the following resources:
• University Area IRB http://cuhs.harvard.edu/
• Longwood Medical Area IRB http://www.hsph.harvard.edu/ohra/
• ESTR Help Desk: ESTRHelp@harvard.edu
20

Study Submission Guide - ESTR Support

Transcription

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