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1.4.1_c3prv2_risks_20061116

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					Risk ID Project/Task Order Name              Type       Risk


                                                       There is no standard way to uniquely identify
                                                       a protocol. This will make it difficult to share
                                                       registration (and other) data between
   602 C3PR Release 2.0 Construction Phase   Technical systems.

                                                       Installation procedure for the existing
                                                       version of C3PR is not well documented.
                                                       Installing the existing version of C3PR may
                                                       take longer time than expected.
                                                       Ramakrishna from SB has been tasked with
   603 C3PR Release 2.0 Construction Phase   Technical performing the implementation.




                                                       C3PR V2 will be the first CTMS application to
                                                       use the caGrid 1.0 security infrastructure
                                                       which itself is currently being developed.
                                                       Due to the relative newness of the caGrid
                                                       1.0 security infrastructure, we may run into
   604 C3PR Release 2.0 Construction Phase   Technical unexpected issues in using it.

                                                       All the API’s necessary for integrating the
                                                       Study Calendar with the C3PR V2 may not
                                                       exist currently. Either the Study Calendar
                                                       team or the C3PR V2 team will have to
   605 C3PR Release 2.0 Construction Phase   Technical develop the necessary API’s


                                                       caXChange is the first caBIG project to use
                                                       the LogicBlaze FUSE ESB. The issues involved
                                                       in using it for implementing the service
                                                       oriented architecture (SOA) are not
                                                       completely known at this point of time. Also,
                                                       the Duke team has limited expertise in using
                                                       it to develop enterprise applications. Issues
                                                       that arise due to the use of the LogicBlaze
                                                       FUSE ESB may significantly hamper the
   606 C3PR Release 2.0 Construction Phase   Technical progress of C3PR V2 development effort.
                                                    There may be IRB issues associated with
                                                    data sharing using the caGrid infrastructure
                                                    between sites cooperating on a clinical study
607 C3PR Release 2.0 Construction Phase   Technical protocol.
Likelihood                                     Impact            Status




5 = 100% (risk as occurred)                    (O) Operational   (PND) Pending




5 = 100% (risk as occurred)                    (M) Moderate      (OCC) Occurred




1 = approximately 25% (possible but not
likely that Risk will occur in next 30 days)   (M) Moderate      (PND) Pending




2 = approximately 50% (chances are even
that risk will occur in next 30 days)          (M) Moderate      (PND) Pending




1 = approximately 25% (possible but not
likely that Risk will occur in next 30 days)   (M) Moderate      (PND) Pending
1 = approximately 25% (possible but not
likely that Risk will occur in next 30 days)   (O) Operational   (PND) Pending
Mitigation Plan                                    Estimated LOE       Actual LOE Date Logged

A standard way to identify protocols in C3PR
will be instituted. This will be investigated by
Ram Chilukuri as it pertains to C3PR V1.
Further tasks will be assigned when that
investigation is complete.                                     20                 11/16/2006 13:58




The Duke team will work with the C3PR 1.x
development to resolve the installation
issues.                                                        36                 11/16/2006 13:59

SemanticBits, which is part of the Duke
team, is also currently involved in the caGrid
1.0 security infrastructure implementation.
We will consult Vinay Kumar and Joshua
Phillips of SemanticBits extensively during
the C3PR V2 security design and
implementation. Taks 38 in the mpp has
been created to address this issue.                                8              11/16/2006 14:01
Ram Chilukuri, who is the lead developer, is
also involved in the Study Calendar
development. He should be able to facilitate
the API development to a great extent. Taks
24 in the mpp has been created to address
this.                                                          36                 11/16/2006 14:04




We request BAH to facilitate setting up
couple of telecon’s with the caXChange
development team to discuss the issues and
lessons learnt in using the LogicBlaze FUSE
ESB.                                                           12                 11/16/2006 14:06
The lead elaborators will investigate
independently with their local IRBs. The
caTRIP IRB application will be used as a
model to infer this. Appropriate changes in
the project plan and development will be
implemented depending on the results.         12   11/16/2006 20:52
Date Identified   End Date Resolution Date   Comments




                                             No comments now - this shouldn't be a
     11/16/2006                              required field.




                                             No comments now - this shouldn't be a
     11/16/2006                              required field.




                                             No comments now - this shouldn't be a
     11/16/2006                              required field.




                                             No comments now - this shouldn't be a
     11/16/2006                              required field.




                                             No comments now - this shouldn't be a
     11/16/2006                              required field.
             No comments now - this shouldn't be a
11/16/2006   required field.
Contingency Plan                             Risk Source




The issue will be raised to BAH and NCICB as
a critical issue in CTMS workflow.           Internal




Development will continue without
deployment of V1.                            External




If unexpected scenarios are identified by the
investigation team, the C3PR development
team will extend the caGrid 1.0 security
infrastructure.                               External




                                             Internal




                                             External
The issue will be raised to BAH and NCI as a
risk to the overall approach of caBIG.
Appropriate workarounds for C3PR will be
determined (potentially using more
traditional technologies such as web
services).                                     Internal

				
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