Transcript F1 Follow Up Form

General Forms Training
RESCUE
Randomized Evaluation of Patients with Stable Angina
Comparing Utilization of Diagnostic Examinations
A Phase III, Multicenter, Randomized, Controlled,
Comparative-Effectiveness Trial
ACRIN RESCUE Data Management
Forms Training
Kimberly Brown, RA
Roberta Clune RA
Bola Shodunke , RA
Victoria Shoyelu, RA
Training Overview
 Main Goals/Aims of Study
 Purpose of Study
 Case Report Forms
 Good Clinical Practices
4701 Main
Goals/Aims
The main goals/aims of the study are:
 To compare outcomes from two different ways to diagnose the cause of your
chest pain using:
 Nuclear medicine cardiac stress test (standard diagnostic imaging test
also known as SPECT MPI)
 Coronary Computed Tomography Angiography (CCTA also known as
Cardiac CT)
 To see if medication prescribed based on the imaging results can safely
prevent or delay the need for an invasive procedure for your heart disease
Purpose of Study

This study will compare outcomes in patients with stable angina who are randomized to
one of two imaging tests for diagnosis-CCTA or nuclear medicine cardiac stress testing
(SPECT MPI)

Estimated costs associated with cardiac-related healthcare after diagnosis using CCTA
or SPECT MPI will be compared to determine the cost-effectiveness of each approach

Quality-of-life tools will be administered to participants to assess differences in well
being between the two diagnostic groups

The diagnostic results will be evaluated to try to create better ways to predict
revascularization, heart attack, or death and therefore to guide treatment after CCTA
results
Data Collection
Case Report Forms
Online Data Management System:
Navigating the ACRIN Website
http://www.acrin.org
Access to all RESCUE
study related
Documents (paper CRFs)
Click RESCUE Field or
Protocol Summary Table
Access 4701 protocol here
Access the paper data forms here
Form Index
 The Form Index provides an outline of
required forms at each visit and additional
forms available if needed
 Pleases refer to the index for current form
version #’s and version dates
Completion Instructions
 The General and Form Specific Completion Instructions
are available on the 4701 Data Forms website
Coordinators Worksheet
for Eligibility
 This worksheet is to aid in
determining eligibility.
Coordinators Worksheet for
Eligibility
AO Form (1 of 3)
There are two A0 data forms, one used with
the initial protocol and the 2nd one with
amendment 1, dated May 4, 2011
The A0 Form is required to register each
participant in the study
At the time of enrollment, the participant
must review, sign, and date the consent
A0 Form (2 of 2)
•
Complete Inclusion and Exclusion
Parts 2 and 3 prior to registration to
determine and confirm study eligibility
•
Submit the A0 form via the ACRIN
data center at www.acrin.org within 24
hours of completion
AO Form (3 of 3)
Protocol section 7.0 describes Registration and
Randomization procedures
•
Please contact ACRIN data management for
manual study registration, in the event that the
website is down.
Initials of person completing the form: Initials of
person(s) responsible for reviewing the data and
completing form.
•
This may be different than the person web
entering the form.
•
Web entry is tracked electronically through the
entry of the username and password.
5.2 Exclusion criteria
5.2.9 History of known left ventricular ejection fraction < 45%:
•
A0 Q39 - Answer should be No to meet eligibility
1. If the most recent Hx of LVEF is <45%, the answer to A0 Q39 could be Yes. However, the
site is allowed to perform another LVEF prior to registering the patient.
• If the new LVEF is > 45%, the patient is eligible and randomized. A0 Q39 = No.
• If the LVEF is still < 45%, the patient is ineligible and not randomized. A0 Q39 = Yes.
2. If the most recent Hx of LVEF is < 45%, and no LVEF is repeated prior to registration, the
answer to A0 Q39 is Yes. The patient is ineligible and not randomized.
3. If the most recent Hx of LVEF is > 45%, and no LVEF is repeated prior to registration, the
answer to A0 Q39 is No. The patient is eligible and randomized.
ACRIN Informed Consent
Page 1 of 2
ACRIN Informed Consent
Page 2 of 2
Please note the very last line
on page 5 of the consent:
“ Your medical records will
continue to be collected until
the end of the study unless
you withdraw your
authorization in writing, as
described in the separate
authorization to release
medical records.”
Participant Contact
Information Sheet (1 of 2)
 Completed by participants at time of consent
which provides contact information for use in
the 12 month QOL sub-study
 Foreign sites are not participating in the QOL
sub-study, therefore this form will be
maintained at the site
 VA sites will use as a worksheet and
maintain at the site
 US domestic sites must fax form upon
registration to both:
1) ACRIN Data Management (215-940-8922) to allow
identification for medical chart procurement requests.
2) Brown University (401-863-9635) for use in the QOL
sub-study at 12 months
Authorization to
Release/Disclose Medical
Records Template (1 of 2)
 Provides ACRIN authorization for
medical chart procurement.
 Completed by participants at consent
 Foreign sites and VA sites do not
submit to ACRIN and should maintain
on site only
 US domestic sites must fax form upon
registration to ACRIN Data
Management (215-940-8922)
Authorization to
Release/Disclose Medical
Records Template (2 of 2)
Letter d specifically states
that revocation of the
authorization must be in
writing to the site and
given to ACRIN.
EK-EKG/Biomarker
Form (1 of 2)

EKG’s performed within 30 days prior to diagnostic
imaging are acceptable

If not performed, unavailable, or not completed within
the 30 days, a new ECG should be completed at the
time of diagnostic imaging (e.g., in the case of ECG
during SPECT MPI);

All participants are to have a 12 lead EKG on file at
ACRIN

Originals preferred but color photocopies are
sufficient

Mail in de-identified EKG with case label to:
ACRIN 4701 RESCUE
Core Lab
1818 Market Street Suite 1700
Philadelphia, Pa 19103-3609

All clinical biomarkers must be reported if drawn within
the previous 28 days of enrollment
EK-EKG/Biomarker
Form (2 of 2)
CR Cardiac Risk
Form
 Access cardiac risk and co-morbidity
criteria for patients with stable angina
 Gray areas indicate questions that the RA
are to ask the participants
 White areas are to be obtained from the
patient/medical record by the RA
 Please refer to the form specific CRF
instructions when completing this form
Diagnostic Imaging – the beginnings of
the Adjudication process
CCTA and SPECT/MPI Reader Forms must be
completed by an ACRIN qualified Radiologist,
Cardiologist or their designated Research Staff.
In unique circumstances where the CCTA and
SPECT MPI Reader Forms are not completed by
an ACRIN qualified Radiologist, Cardiologist, etc.,
a PR form is required.
CCTA Reader Form (1 of 2)
The purpose of this form is to collect
clinical, diagnostic and radiological data
that occurs with CCTA Imaging (Group A).
Positive cardiac findings on the CCTA
are defined as:
1) ≥ 50% stenosis on CCTA OR
2) Un-evaluable left main, or proximal
and mid segments of all other
epicardial arteries (right coronary
artery, left anterior descending artery,
or left circumflex artery)
Tip: Follow-up for a MACE event at the 2
week and 2 month timepoint will be
required when there is a > 50% stenosis in
any of the vessel segments, e.g. obtuse
marginal
CCTA Reader Form (2 of 2)
Question #7:
Incidental Findings on the CT are any
other findings found on the contrast or
non-contrast runs of the Coronary CT
angiograms scans.
Questions #9 and #10
Reference the Schema to determine the
treatment arm for > 50% stenosis vessel
Question # 11
Any other stenosis noted less than 50%
will be treated according per institution
standard of care and None is an
appropriate choice .
CT Reader Form
Summary
If Research Staff have questions or discrepancies regarding the CCTA data, they
are to seek the guidance of the reader who interpreted the participant’s CCTA before
submission to ACRIN.
Incidental Findings on the CT are any other findings found on the contrast or noncontrast runs of the Coronary CT angiograms scans.
If any LM (left main) disease of > 50% is seen on CT, participant should go to ICA
(cardiac catheterization) per protocol.
If any other vessel other than the LM is determined > 50% in diameter, participant
should go to OMT (optimal medical therapy) per protocol.
If any proximal or mid cardiac vessel segments are indeterminate, participant should
go to OMT.
Any other stenosis noted less than 50% will be treated according per institution
standard of care and None would be an appropriate choice for this scenario. (Q11)
TC- CCTA Technical
Assessment Form
 Completed within two weeks of consent for
participants who undergo contrast-enhanced CCTA
(Coronary Computed Tomography Angiography)
following randomization to Group A for the evaluation of
suspected CAD (Coronary Artery Disease)
 This form’s main purpose is to record whether or not the
scan was completed, scanner details, contrast and
medications given
 A CCTA is done in 2 phases- the non-contrast ‘run’ and
the contrast ‘run’. The non-contrast run is done first
before the injection of the contrast. This captures the
heart calcium score. Often if calcium scores are too
high, the CCTA will not be completed with the contrast
run. The non-contrast run will also detect incidental
findings in other anatomical areas
 If AE’s were present, the AE form should be completed
SP- SPECT MPI Reader
Form (1 of 2)
 The purpose of this form is to collect clinical,
diagnostic and radiological data that occurs
with SPECT Imaging (Group B). This is the
standard of care imaging.
 For a positive SPECT perfusion scan, there
are three scenarios that will make it
positive for trial endpoint surveillance:
1) > 10% reversible defect size (Q16a)
2) If SDS is > 7 (Q16c)
3) Positive EKG changes for ischemia (Q9) and
Transient Ischemic Dilation observed (Q18a)
 1-3 indicate a positive scan, therefore the
response to Q19 should be Yes
SP- SPECT MPI Reader
Form (2 of 2)
 If there were positive results found, the
correct treatment should be “Diagnostic ICA”
to (Q20)
 If scans were negative the correct response
should be “None” to (Q20) and the participant
should be followed with OMT (Optimal
Medical Therapy) per protocol and physician
decision
TS- SPECT Technical
Assessment Form

Completed within one week of registration,
documents if a SPECT was performed, and some
imaging and contrast information associated with
the SPECT (Group B).

SPECT MPI scans can collect images during rest
and stress. Not all SPECT MPI scans require
imaging during rest and vice versa. If rest images
were only obtained at one sitting, the participant
may be asked to have a repeat scan (SPECT or
other type of scan) to try to image the heart during
stress to capture ischemia. Stress images are
captured while exercising, or if exercise is not
tolerated, induced by medication.
I2 Alternative
Imaging Form
 This form is optional and is used
only if either the SPECT or the
CCTA was non-diagnostic or
uninterpretable. It will be
triggered onto the case calendar
automatically by the TS or TC
form
 Captures ‘crossover’ of
randomization arm for analysis,
information if scans are repeated,
and primary endpoint data should
another means of imaging be
used for proper cardiac diagnosis
I3 Randomized
Alternate Imaging form
This form is optional and is used
only if either the randomized
SPECT or the randomized CCTA
were not performed. It will be
triggered onto the case calendar
automatically by the TS or TC
form
MA MACE Incident
Form (1 of 2)
 To be completed by Research Staff after
a telephone call with the participant or
proxy at two weeks and two months
after enrollment for participants who
have positive cardiac findings on
diagnostic CCTA (> 50% left main
stenosis) or SPECT MPI (> 10%
reversible perfusion defect or EKG
changes for ischemia with positive TID).
 Form is triggered on the calendar for
positive scans at baseline
 Completed when participant has a heart
attack, stroke, revascularization, or dies
MA MACE Incident
Form (2 of 2)
 Events reported on this form are sent
to the adjudication committee for
review
 With every MACE event, fax the
participant contact sheet (excludes VA
sites) to ACRIN DM dedicated fax line
215-940-8922
MACE INCIDENT FORM
Summary
Follow up at the site will comprise telephone participant/proxy contact at 2
weeks and 2 months after enrollment only for participants who have positive
cardiac findings on diagnostic CCTA or SPECT MPI. See protocol section
8.2.1 for additional details.
F1 Follow Up Form

Completed by for all participants at various follow-up time points

The purpose is collect vital status, information pertaining to the diagnosis, treatment
and procedures the participant has had during follow-up. It also captures optimal
medical therapy (OMT) and medical provider information

Needs to be completed at each 6-month time point, whether contact is made with the
participant or not. The form related to 6-month follow up, for example, should not be
completed until contact has been made (four [4] attempts) or other confirmation of
participant’s vital status (e.g., record review or known death) has been verified

The participant’s medical record should not be reviewed for vital status until contact at
the final follow up time point has been attempted four (4) times. The final follow-up
time point will be dependent on the enrollment timing of the participant
F1 Follow Up Form
(1 of 8)
F1 Follow Up Form
(2 of 8)
F1 Follow Up Form
(3 of 8)
F1 Follow Up Form
(6 of 8)
F1 Follow Up Form
(8 of 8)
Q21: Were there any changes in the
participant contact information since last
contact or study follow-up?
Answer = Yes, update Participant Contact
Sheet and efax to 215-940-8922
HS Participant Health
Survey (1 of 3)
 Completed at initial visit, and is a
standardized research tool that measures
quality of health
 At the one year follow up there will be a
randomized subset of participants who will be
sent this questionnaire in the mail by the by the
Outcomes Research Department of Brown
University
 If a VA institution participant is selected, it will
be asked of the site and the VA participant to
complete the form in the office and mail it
directly to Brown University
 If a non-VA institution participant is selected, it
will be mailed to the participants home for
completion and the participant will be required
to mail it back to Brown University
HS Participant Health
Survey (2 of 3)
HS Participant Health
Survey (3 of 3)
SA Seattle Angina
Questionnaire
 Completed at initial visit, and is a standardized
subjective tool/questionnaire that measures the
quality of health in persons who live with chest pain
or angina
 Just like the HS form, at the one year follow up
there will be a randomized subset of participants
who will be sent this questionnaire in the mail by
the Outcomes Research Department of Brown
University
 If a VA institution participant is selected, it will be
asked of the site and the VA participant to complete
the form in the office and mail it directly to Brown
University
 If a non-VA institution participant is selected, it will
be mailed to the participants home for completion
and the participant will be required to mail it back to
Brown University
 Please note only page 1 of 3 is shown here
LS Life Style Form
(1 of 2)
 Completed at baseline and
12 months
LS Life Style Form
(2 of 2)
OF Off Study Form
 Documents when a participant goes off-study
for any reason
 It should be submitted within two weeks of
completion/disposition date
Adverse Event (AE):
 The AE form is to be completed for each reportable AE
the occurs during the study. The adverse event
reporting section in the protocol will specify reporting
requirements
 This form must be signed/assessed by the PI.
 Please reference the form specific completion
instructions
 If further clarification is required for any of the
questions on this form, please contact the ACRIN AE
Coordinator
AE Adverse Event
Form
SR Serious Adverse
Event (1 of 2)

Completed only for reportable Serious Adverse
Events

Please refer to AE section 10.0 in the protocol
for further details and definitions regarding
SAE’s

The PI is responsible to determine reportability
and review of all SAE event criteria/information
to be reported to ACRIN

This form is submitted to ACRIN only and
reviewed by the group chair and safety
committee
SR Serious Adverse
Event (2 of 2)
PR Protocol Variation
Form (1 of 2)

Completed to report protocol variations

Complete a separate form for each case and
for each variation

Each institution’s IRB may also have
separate reporting requirements for protocol
variations

Please be very specific about the protocol
variation and provide details on what was
done to rectify the situation
PR Protocol Variation
Form (2 of 2)
CM Communication
Memo
Completed:
1) When a protocol/calendar required item is
unavailable or unable to be submitted to
ACRIN
2) To communicate information pertinent to a
forms due request
3) To communicate case-specific data
corrections which were inadvertently entered
via the online Web system
4) To communicate audit or monitoring findings
which resulted in a data correction
 Each communication memo should be case
specific
 Retain in participants case file and fax/mail a
copy to ACRIN Data Management Center
GCPs
Good Clinical Practices:
Documentation
Incorrect GCP
Correct GCP
Contact Information
4701 Research Associates
 Victoria Shoyelu – Lead Data Manager
 [email protected]
 215-717-2767
 Roberta Clune AS, LPN - Co-lead
 [email protected]
 215-574-3184
 Kimberly Brown
 [email protected]
 215-717-2761
 Bola Shodunke
 [email protected]
 215-717-2761
Questions ?