Monthly Status Report FIREBIRD

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Nov 29, 2012 (4 years and 8 months ago)

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Monthly Status Report

FIREBIRD January 2012











5AM Solutions, Inc.


Monthly Status Report



FIREBIRD


Subcontract #29XS218 TO 05



January 2012

Status Report








Submitted by: Rashmi Srinivasa

rsrinivasa@5amsolutions.com


February

1, 2012


Project Background/Objectives

Brought together by a common desire to manage clinical investigator information securely and
electronically, the NCI, FDA, and industry entities united to facilitate the exchange of clinical research
information between NCI and FDA. The result was the Fede
ral Investigator Registry of Biomedical
Information Research Data (FIREBIRD) of the FDA and NCI’s Interagency Oncology Task Force (IOTF).
Envisioned as a web application to facilitate communication between clinical trial sponsors, investigators,
and the FD
A, while employing a digital signature technology to make a formerly paper
-
based process
completely electronic, FIREBIRD
is

intended to function as the global investigator registry for commonly
referenced data and a secure storage of regulatory submission
information that could be easily queried
.

After
the

initial pilot phase, our team has been engaged to develop the next ge
ne
ration of FIREBIRD


version 3.x
.

The project also includes design and development of a credential service.


Technical Overview

The h
ighlights of

FIREB
IRD 3.x

are as follows:



A new and improved application workflow.



Integration of the NCI Enterprise Services (NES).



Development of a

Credential service and integration within the FIREBIRD workflow.



Digital Signature
capability
.

FIREBIRD

is developed as an open source product,
and our

basis is the
CBIIT
20
10 technology stack.
We use the Postgresql 8.4
.x relational database, Java 1.6
, and the Jboss 5
.1

application server. We use
Hibernate for our
object relational mapping layer

and EJB3 de
clarative transactions
, both

provided by the
JBoss container. We
also
use
jQuery and Struts 2
. Code quality
is

enf
orced via static analysis tools

such
as PMD,

Checkstyle, and Cobertura. Coding

standard
s

adherence

and unit test code coverage
thresholds
are

verified
via continuous integration
.



Personnel Roster

Name

Title/Role

Eric Tavela

Tech Lead/Senior Software Engineer

Adam Swift

Software Engineer

Ryan Kumsher

Software Engineer

David Loose

Senior Mgmt Consultant/SME

Tanya Shedrick

Requirements
Analyst

Rashmi Srinivasa

Project Manager


Current
Technical Status

The team has

released several

milestones
to QA, focusing

on
full integration with the NES Person and
Organization services,
account login, management of

investigator profile information,
creation of a
protocol
-
based registration packet,
management of documents in the registration packet, investigator
invitation,
registration completion,
registration review,
digital signatures
, audit log, Section 508
compl
iance

and
bug fixes.
We have also
attended

regular

meetings with the NCI’s Division of Cancer
Prevention (DCP) in order to
provide status and solicit

their feedback
, and have conducted
three

UAT
session
s

with DCP leadership
.

Last month
, the team
addressed
the remaining high priority improvements and several of the critical bug
fixes.
We
continued with the biweekly

strategic planning meetings

w
ith CBIIT and SAIC
-
F leadership
, and
are actively addressing the deployment dependencies that must be met in order f
or the DCP to be able to
use the system
. We
have

started
the C&A process, written flowcharts and SOPs for account management
and identity verification, and are preparing for a Rebranding market research effort
.

The Production tier is
being provisioned and
made ready for deployment.

Nex
t month
, we
plan to finish

fixing the critical bugs, run the security app scan, and prepare for
Production deployment.
We will
also continue addressing the deployment dependencies
.



Description of Work Completed During the
Month


External Meetings

(Summarize for Frequent Communications)


Date

Topic

Project Attendees (Optional)

Daily

Developer/
QA/Analyst

scrum


Biweekly

Iteration Retrospective and P
lanning


Biweekly

Strategic Planning meetings with CBIIT and
SAIC
-
F


Biweekly

Contract meetings with COTR


Monthly

Demo
s

to the

DCP to demonstrate progress


Bi weekly

Mid
-
iteration user story review and bug triage
meetings


As needed

Design
and bug
-
fixing

meetings




Technical
Progress


Activity

Description

Requirements

analysis



Developed the SOP requirements to support the FIREBIRD account
registration and digital signature identity verification processes.



Finalized producing the content and mockups for the user stories that support
the following functionali
ty:



FB
-
1899: Update the LDAP account request process so that applicants are
required to specify what role they will be requesting in FIREBIRD.



FB
-
415: An Investigator without an existing FIREBIRD account should be
able to request an account via a link in a

registration invitation email.



FB
-
677: As an Investigator, I want to be able to invite an existing FIREBIRD
user to be my Registration Coordinator.



FB
-
1757: As a Registration Coordinator, I would like to have a task list item to
notify me when I have regi
strations that have not been submitted to the
Sponsor for the Investigators that I'm managing.



FB
-
1683: Modify the verification screen to clearly display which documents
were signed and add a warning before digital signing.



FB
-
1758: As an Investigator, I c
an remove an Organizations association, but it
will not remove it from registration packets that have been submitted.



FB
-
1723: As a Sponsor, I would like to be able to export Protocol Registration
data.



FB
-
413: The Sponsor should be able to invite an Inves
tigator by supplying
only email address.



FB
-
1817: FIREBIRD needs to have the ability to handle international
addresses for both organizations and persons.



FB
-
1793: As a newly registered user, I would like a pop
-
up notification that
warns me of my limited
functionality until approvals are made.



FB
-
1674: AP
-
12. General email box (REGULATORY@CCSAINC.COM) for
DCP



FB
-
1462: No instructions for a caGRID user about Digital Signing and Identity
Verification Documentation

Completed iteration
s
42,
43

and
4
4

Iteratio
n

42
:
https://wiki.nci.nih.gov/display/FIREBIRD/FIREBIRD+3.0+Iteration+42


Themes
:



International addresses
.



Other critical improvements/
feedback items.

Iteration
43
:
https://wiki.nci.nih.gov/display/FIREBIRD/FIREBIRD+3.0+Iteration+43


Themes:



Ability to change roles.



Duplication of digital signature field.



Other critical leftover items
.

I
teration 44:
https://wiki.nci.nih.gov/display/FIREBIRD/FIREBIRD+3.0+Iteration+44


Themes:



Sponsor's
Ability to remove Sponsor Delegates; Add Lead Organization;
Revision of
user
-
facing messages.



Critical Bug Fixes
.

Stakeholder management



Prepared for and led the FIREBIRD rebranding discussion
.



Continued with the biweekly

strategic planning meetings with Jose Galvez,
Hemant Undale and Dr. Gisele Sarosy.


Task Status

(See Detailed Technical
Implementation
Task Details at the bottom.)


Task

Status (% completed)

Comments









Work Planned for Next Month


Activity

Description

Requirements analysis and
stakeholder
management



Work on deployment dependencies
including C&A,
Rebranding, SOPs, etc.



Begin finalizing all use case specifications in
preparation for the production readiness review
.



Support CTEP engagement
.



Provide ongoing updates to CCCT

and the DCP
.

Iterations
4
5

and 4
6

Fix Critical and Blocker bugs

Review and u
pdates of
deliverables


Standing meetings

I
teration planning meetings, scrums,
design/
planning
meetings
, updates to the DCP/CCCT
.




Issue Man
a
gement


The latest information on r
isks

to the project can be found here:
https://ncisvn.nci.nih.gov/svn/firebird/trunk/docs/project_management/FIREBIRD_Risks.xlsx


ID

Description

Owner

Actions

Priority

Status
(Open,
Closed)

I1

High LOE of
implementing a
standalone
credentialing service

Rashmi
Srinivasa

Since there is no known
user for the credentialing
service other than
FIREBIRD, the
credential managemen
service implementation
has been pushed to
Year 2.
This has been
approved by the COTR
and John Speakman.

High

Closed

I2

Development scope for
Year 1 is too high

Rashmi
Srinivasa

We have proposed an
alternative scope and
schedule which has
been accepted by the
COTR, John Speakman
and Dr. Sheila
Prindiville
.

High

Closed

I3

QA testing has fallen
far behind development

Rashmi
Srinivasa

The new QA tester
started in July 2011, and
we will work with him to
ensure that QA catches
up with the last 5
untested iterations, and
starts on an automated
regression
testing suite.

High

Closed

I4

The lightweight
approach to identity
verification,
authentication and
digital signatures was
deemed unsatisfactory.

Rashmi
Srinivasa

For the moment, we are
proceeding with the
single
-
factor approach in
the interest of getting

the
rest of the application
built. The schedule will
need to be revisited
once the scope for multi
-
factor authentication
becomes clearer.

High

Open

I5

The DCP stakeholders
have been unavailable
for requirements
gathering and
validation for a long
time.

T
his increases
the risk of unknown
requirements and
possible rework of
already
-
implemented
features.

Rashmi
Srinivasa

We have been
proceeding with
implementing features to
our best understanding
and will have to rework
later if required by the
stakeholders.


High

Open



Risk Management

The latest information on r
isks

to the project can
always
be found here:
https://ncisvn.nci.nih.gov/svn/firebird/trunk/docs/project_management/FIREBIRD_Risks.xlsx


ID

Description

Owner

Potential
Impact

Mitigation/Status

Priority
(H, M, L)

Status
(Open,
Closed)

1

Credentialing work
started earlier for
COPPA may bias
the
expectations for
the FIREBIRD
credentialing service.

Nobody

Medium

Define vision and get it
reviewed by stakeholders.

Low

Closed

5

It is unclear who has
the authority to
approve
requirements and
design for digital
signatures, including
Part 11 compliance,

which may delay
approval and
increase the risk of
rejection.

Nobody

High

Identify the stakeholder(s)
with authority to approve
requirements and design.

Low

Closed

6

Due to negative
experiences with
previous
incarnations of
FIREBIRD, DCP
may not fully
embrace the project.

David
Loose

High

Demonstrate early on that
FIREBIRD 3.0 is
addressing some the key
issues that contributed to
DCP's earlier negative
experience. Continue to
demonstrate in each
subsequent demo that we
continue to address their
concern
s.

High

Closed

8

The price proposal
assumed a
lightweight identify
verification
requirement. If the
requirement is more
complex, the
implementation may
be more costly than
the contract can
sustain.

David
Loose

High

Clearly document our
understanding of
the
vision for this service
based on the historical
FIREBIRD requirement
discussions and current
industry practices. Identify
the stakeholder(s) with
authority to approve
requirements and design
(Braulio Cabral, George
Komatsoulis and Bruce
Woodcock
-

CIO)
. Review
our proposed approach
with them, highlighting the
impact of increasing the
complexity.

Low

Closed

11

The scope of the
credentialing service
is poorly defined at
the moment. When it
does become well
Nobody

High

Get our vision and design
reviewed by the ESST.

High

Closed

defined, the LOE
may turn out to be
higher than

originally
expected.

13

As the use cases for
various parts of the
application get
fleshed out, it is
becoming unlikely
that all of the scope
originally proposed
for Year 1 will be
possible to
accomplish with the
current team size.

Rashmi
Srinivasa

High

Break down the high
-
level
adoption priorities into
tasks, estimate the LOEs
and compare to the team
velocity to see if scope
needs to be revisited.
Reprioritize tasks instead
of full
adoption priorities.

High

Closed

15

Since FIREBIRD
supports FDA
-
regulated
transactions and
maintains FDA
-
regulated
documentation, it is
beholden to 21 CFR
Part 11 Compliance.
Compliance is
typically
demonstrated
through independent
validation against
Part 11
requirements, which
is not in the remit of
the Firebird team
and is not typically
the remit of the
development team
but rather an
independent QA
body.

Hemant
Undale

Medium

QA team responsible for
Part 11 compliance
testing.

Low

Closed

3

Leveraging

the NES
may limit
performance and
functionality

Eric Tavela

High

Monitor the performance
and functionality
improvements of NES as
we approach our release.
Raise visibility of issues
through demos and briefs.
Consider saving up
updates and sending a
batch
request to NES.

High

Open

4

If we're able to help
OEWG implement
some mandates, we
may be able to enlist
their support;
conversely, if we
can't help,
FIREBIRD may be
David
Loose

Low

Discuss with CTEP PIO
Chief on possible ways for
Firebird to aide OEWG
response. Due to
divergent timelines, we
may only be able to assist
with the broader long
-
term
goals of reduced study
Low

Open

pushed to the bottom
of their priorities.

inititation timelines, but the
CTEP investigator
registration proc
ess is not
currently a major delay to
study initiation due to a
number of established
release points (i.e. ways to
push through study
activation without waiting
on PI registration)

7

Currently, curation

of
persons and
organizations
depends on the
CTRO/CTRP
contract and their
deployment
timelines. If curation
isn't available when
FIREBIRD is ready
to deploy, CTEP and
DCP won't use it.

Hemant
Undale

High

We are looking to SAIC
-
F
to manage this risk as thi
s
has to do with the
CTRO/CTRP contracts.

Medium

Open

9

Any delay in CTEP
integration and use
of NES for
person/org
management may
impact CTEP's ability
to use Firebird.

Hemant
Undale

High

We are looking to SAIC
-
F
to manage this risk

as this
has to do with the CTRP
contracts.

High

Open

10

Old incarnations of
FIREBIRD
developed a
reputation for being
excessively
complicated and
difficult to use, which
may impact adoption
going forward.

David
Loose

Medium

Engage with DCP in the
first
year to gain their
sponsorship; Hold regular
stakeholder meetings to
solicit feedback on
requirements and design,
and demo newly
implemented functionality.
Expand to CTEP in the
following year. Engage
with outside/other
stakeholders throughout to
keep the
m apprised of
progress and demo new
developments.

Low

Open

12

Investigators and
others users may not
be available to
support the
gathering and
refinement of
requirements.
Limited input from
end users may
negatively impact the
quality and usability
of the

end product.

David
Loose

High

The team has begun
regularly engaging with
DCP, as per the adoption
plan for engaging
stakeholders/users. We
have executive
sponsorship at DCP in Dr.
Leslie Ford; but we also
need to keep the
operations people happy.
To that

end, David and
Tanya we plan to do
High

Open

monthly updates at a
minimum to keep the core
operations group
engaged: Judy Smith and
Margaret Schetrum.

14

The DCP has
expressed a desire
for all of the NCI to
move to one way of
doing registrations. If
they

switch to doing
annual registrations
only, then our per
-
protocol registration
implementation will
become wasted
effort.

David
Loose

Medium

The likelihood of such a
switch to annual
registration is low,
especially in the short
term. We are keeping
DCP enga
ged so that we
are aware of any such
developments. Our team
follows an Agile approach,
so changes in
requirements can be
handled relatively
smoothly.

Low

Open

16

Several user stories
that were not
previously recorded
on the backlog have
now been identifie
d
after clarifications
with the DCP. This
means that the
backlog is quite
bigger than it was at
the time the project
schedule was
determined.

Rashmi
Srinivasa

Medium

Streamline process,
prioritize backlog tightly,
communicate risk.

Medium

Open

17

There are duplicate
organizations (same
name but different
addresses) and
misspelt organization
names in NES. This
makes it difficult for
users of a consumer
application like
FIREBIRD to
determine which
person or
organization to
select.

Hemant
Undale

Medium

Display more information
than merely the name so
that the user can select
appropriately.

Medium

Open

18

Increase to scope if
CTEP IAM
integration is
required

Rashmi
Srinivasa

High



High

Open

19

Investigator
dissatisfaction and
increase to scope
if
Dorian to NCI LDAP
migration is required

Jose Galvez

Medium



Medium

Closed

20

A combination of
unplanned leave and
Rashmi
Srinivasa

High



High

Open

planned leave on the
QA team's part has
delayed the testing
of the product
.


Status of
Milestones


Mileston
e

Delivery Date

Status

Project Kickoff

May 12,

2010

Completed

Design Review

August 18,

2010

Completed

Deliverables Readiness Review


Not yet
scheduled

Project Completion

and Project Summary Report


Not yet applicable


External Dependencies


Dependency

Date

Status

Comments

Architecture

review

Ongoing

The ESST reviews and
provides feedback on
our architecture
.


Documentation

Ongoing

Carolyn Klinger has
been

engaged
as of

March
2011
.


QA
Testing

Ongoing

Ekagra

is

responsible
for testing the product.





Status of Deliverables

(Updates this month are highlighted in yellow.)

Contr
act
Delive
rable
Numb
er

Contract
Deliverable
Name

Project
Artifact
Name

Working

Copy
Link

Final
, Published Copy Link

Due Date

Date
Delivered

Status

1.1

Project
Plan,
Deliverable
Managemen
t Plan,
Communica
tion

Plan

Project
Manage
ment
Plan


https://ncisvn.nci.nih.gov/svn/fire
bird/trunk/docs/project_managm
ent/Project_Management_Plan.doc
x

https://ncisvn.nci.nih.gov/svn/fireb
ird/t
runk/docs/project_manageme
nt/FIREBIRD_3.0_Project_Plan.xl
sx

Every
month as
needed

Every month
as needed

(
November

30
, 2011)

Complete

1.2

Monthly
Status
Reports

Monthly
Status
Reports


https://ncisvn.nci.nih.gov/svn/fire
bird/trunk/docs/project_managm
ent/monthly_status_reports/

Gforge location:
https://gforge.nci.nih.gov/docman
/index.php?group_id=216&selecte
d_doc_group_id=5869&language_id
=1


Every
month
before the
10th

February

1
,
201
2

Complete
up to last
month

1.3

Project
Summary
Report

Project
Summar
y Report



Last
month of
project


Not yet
applicable

2.1

FIREBIRD
Vision and
Scope
Document

FIREBI
RD
Vision
and
Scope
Docum
ent


https://ncisvn.nci.nih.gov/svn/fire
bird/trunk/docs/project_manage
ment/FIREBIRD_Vision.doc

August
18, 2010

June 25,
2010

Complete

2.2

Use Case,
and
Software
and
System
Requireme
nts and
Specificatio
ns





https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/requirement
s

https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/credentialin
g_service



Initial set
due
August
18, 2010

Next
review
during
Deliverabl
es
Readiness
Review

September

15
, 2011



Complete
up to last
month

2.3

Updated
Architectur
e and
Design,
UML Model



https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/analysis_an
d_design/architecture/firebird_
software_architecture_docume
nt.doc


Initial set
due
August
18, 2010

Next
review
during
Deliverabl
es
Readiness
Review

Apr 26,
2011



Complete,
pending
addressing
of

COTR
comments

2.4


Updated
Implement
ation Plan



https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/analysis_an
d_design/FIREBIRD_Impleme
ntation_Plan.doc

Initial set
due
August
18, 2010

Next
review
during
Deliverabl
es
Readiness
Review

Jan 11,
2011

Complete

3.1

FIREBIRD
Support
and
Maintenanc
e
Procedure;
Data
Migration
Plan and
Data
Migration
Scripts



https://ncisvn.nci.nih.gov/svn/fireb
ird/trunk/docs/project_manageme
nt/FIREBIRD_Deployment_P
lan.d
ocx


During
Deliverabl
es
Readiness
Review

Feb 8, 2011

Complete
(part of
Deploymen
t Plan
deliverable)

3.2

Updated
SDLC
documenta
tion taking
into
account
NES
integration
and
credentialin
g service

See
Implem
entatio
n Plan,
SAD
and
credent
ialing
service
scope
deliver
ables.

N/A

N/A

N/A

N/A

See
Implement
ation Plan,
SAD and
credentialin
g service
scope
deliverable
s

3.3

FIREBIRD
Complianc
e Reports
for BRIDG
and BAM



BRIDG compliance:
https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/analysis_an
d_design/FIREBIRD3_BRIDG
-
BasedAnalysisModel.EAP

BAM compliance:

https://ncisvn.nci.nih.gov/svn/f
Initial set
due
August
18, 2010

Next
review
during
Deliverabl
es
Last
Updated
Dec 14,
2010

Complete

irebird/trunk/docs/analysis_an
d_design/20101013_FIREBIR
D_TraceMatrix.xls


Readiness
Review

4

TASK 4
deliverable
s were
removed
as part of
contract
modificatio
n 1

N/A

N/A

N/A

N/A

N/A

TASK 4
deliverable
s were
removed
as part of
contract
modificatio
n 1

5.1

Adoption
Plan
Template

FIREBI
RD
Adoptio
n Plan


https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/project_man
agement/FIREBIRD_Adoption
_Plan.docx


August
18, 2010

Last
Updated
Feb 16,
2011

Complete

5.2

Adoption
Report
Template



https://ncisvn.nci.nih.gov/svn/fireb
ird/trunk/docs/requirements/Stake
holder/FIREBIRD_Adopter_Asses
sment_Form.doc


During
Deliverabl
es
Readiness
Review

Apr 4, 2011

Complete

6.1

Compatibili
ty Review
Submission
Package




During
Deliverabl
es
Readiness
Review


The silver
review
process is
obsolete
and the
new
compatibilit
y review
process
has not yet
been
defined by
CBIIT.

6.2

BDA
Complianc
e Package



https://wiki.nci.nih.gov/display/sys
deploy/CTMS+
-
+Firebird+Systems+Deployment+
Documents


During
Deliverabl
es
Readiness
Review

Last
Updated
Jan 27,
2010

BDA
project plan
has been
followed.
The BDA
dashboard
has been
retired, and
related
deliverable
s are no
longer
valid.

6.3

ECCF
Documenta
tion (CFSS,
PIM, PSM)



https://ncisvn.nci.nih.gov/svn/f
irebird/trunk/docs/credentialin
g_service/Qualifications_Servi
ce_Scope.doc


Initial set
due
August
18, 2010

Next
review
during
Deliverabl
es
Readiness
Review

Apr 6, 2011

Scope
delivered;
CIM, PIM
and PSM
will be
delivered in
Y
EAR 2
when the
credential
manageme
nt service
is
implemente
d

6.4

Registered
Grid
Service




2012


Credential
manageme
nt service
will be
implemente
d in the
year 2012

6.5

Data
Sharing
Plan (if
applicable)




During
Deliverabl
es
Readiness
Review


N/A

7.1

FIREBIRD
Demonstrat
ion Web
Site



http://firebird
-
demo.nci.nih.gov


During
Deliverabl
es
Readiness
Review

May 31,
2011

Complete

7.2

Updated
FIREBIRD
Deploymen
t Plan



https://ncisvn.nci.nih.gov/svn/fireb
ird/trunk/docs/project_manageme
nt/FIREBIRD_Deployment_Plan.d
ocx

During
Deliverabl
es
Readiness
Review

Feb 1
6,
2011

Complete

7.3

FIREBIRD
Downloada
ble
Installation
Package of
each
release
along with
Source
Code



https://ncisvn.nci.nih.gov/svn/f
irebird/tags/3.0
-
it42/


https://ncisvn.nci.nih.gov/svn/f
irebird/tags/3.0
-
it43/


https://ncisvn.nci.nih.gov/svn/f
irebird/tags/3.0
-
it44/


Up t
o date
at the end
of each
iteration

January

3
0
,
2011

Complete

7.4

Release
Notes




During
Deliverabl
es
Readiness
Review


Not yet
applicable

8

FIREBIRD
Programm
er Guide
and API



During
Deliverabl
es
Readiness

Not yet
applicable

documenta
tion

Review

Monthly Status Report

FIREBIRD January 2012


Technical
Implementation
Task Details


Iteration
42


Bug



[
FB
-
1510
]
-

IE8: Screen does not return when "Enter" key hit while logging in to
submitting forms for digital signatures



[
FB
-
1730
]
-

Swapping person records causes EJBTransactionRolledbackException on t
he
system

Task



[
FB
-
820
]
-

AP
-
5. Remove all instances of Date of Birth



[
FB
-
1783
]
-

Implement email "to" address override for testing

Use
r Story



[
FB
-
422
]
-

AP
-
11. An Investigator should be able to add documents not requested by the
Sponsor to their protocol registration submission.



[
FB
-
1462
]
-

No instructions for a caGRID user about Digital Signing and Identity
Verification Documentation



[
FB
-
1674
]
-

AP
-
12. General email box (REGULATORY@CCSAINC.COM) for DCP



[
FB
-
1786
]
-

As a Sponsor, I only want to review forms/documents that have been marked
as Rejected when an Investigator submits a registration packet that was Returned for
corrections.



[
FB
-
1791
]
-

As a Sponsor, I would like to have an indicator identifying forms that were
modified when an Investigator re
-
submits a registration packet that was returned long
with the ability to view comments left

by that investigator.



[
FB
-
1793
]
-

As a newly registered user, I would like a pop
-
up notification that warns me
of my limited functionality until approvals are made.



[
FB
-
1817
]
-

FIREBIRD needs to have the ability to handle international addresses for
both organizations and persons.




Iterat
ion
43


Bug



[
FB
-
1662
]
-

No error
message when a degree from a foreign university (non USA) is
added the Investigator by a CTEP id search



[
FB
-
1726
]
-

IE8: Sponsor unable to add Investigator to a protocol for registration

User Sto
ry



[
FB
-
1680
]
-

AP
-
11. For signed versions of all forms, duplicate the date from the digital
signature in any applicable date field.



[
F
B
-
1697
]
-

AP
-
6. As a registered user, I would like to add or change my roles.



[
FB
-
1815
]
-

Sponsor delegates should not be able to create/edit/import protocols nor
should the
y

be able to add/invit
e/remove investigators to a registration.


Iteration
44


Bug



[
FB
-
633
]
-

Certificate can be added with an expiration date less than the effective date



[
FB
-
1026
]
-

FIREBIRD to NES Organization role mapping for ClinicalLaboratory is
incorrect



[
FB
-
1235
]
-

Rejecting a registration form marks

the status as "Returned" and not
"Incomplete"



[
FB
-
1275
]
-

Completed Registration status does not include timestamp



[
FB
-
1276
]
-

Sponso
r completed registration to be marked as Complete and not Finalized



[
FB
-
1333
]
-

"Submitted" forms are not marked as "In Progress" when protocol changes
are made by the Sponsor



[
FB
-
1335
]
-

"Approved (Finalized)" forms are not marked as "In Progress" when
protocol changes are made by the Sponsor



[
FB
-
1361
]
-

IE8: Hit enter while o
n Protocol Change Agents Search box hangs IE8



[
FB
-
1520
]
-

IE8: Display is distorted when a long list of Investigators need to be invited
for protocol registration

Task



[
FB
-
1248
]
-

Create SOPs for Security Administrator to approve an Investigator or
Sponsor account.



[
FB
-
1937
]
-

Prepare FIREBIRD PROD provi
sioning request

User Story



[
FB
-
675
]
-

AP
-
18. The Sponsor should be able to remove sponsor delegates for their
sponsor organization.



[
FB
-
811
]
-

AP
-
9. Add Lead Organization to the Create a Protocol Screen



[
FB
-
1678
]
-

AP
-
10. Update the content of the task list and email invitation for a protocol
registration to include whom to conta
ct in case they have been invited in error.



[
FB
-
1686
]
-

AP
-
11. All text related to error messaging, headings, and email content
needs to be re
-
examined for consistency and ease of interpretation



[
FB
-
1689
]
-

AP
-
6. During the account registration process, the system should use
information retrieve during authentication to search for the NES records.