> **\
> Clinical Trials Management Systems Workspace**
>
> **Face-to-Face Meeting**
>
> **Oregon Health & Science University**

SESSION: PLANNING / MONITORING SIG BREAK-OUT

+------------+---------------------------------------------------------+
| Session    | Date: May 30, 2007                                      |
| I          |                                                         |
| nformation | Time: 1:30 PM -- 3:10 PM                                |
|            |                                                         |
|            | Presenter/Lead: CTMS Lead: John Speakman                |
|            |                                                         |
|            | DSIC Lead: Elaine Brock                                 |
|            |                                                         |
|            | Facilitator: Diane Rickman                              |
|            |                                                         |
|            | Scribe: Susan Varghese                                  |
+------------+---------------------------------------------------------+
| Executive  | John Speakman presented an overview of the Planning/    |
| Summary    | Monitoring SIG in terms of its goals and the various    |
|            | projects that fall under this SIG. Considerable         |
|            | discussion occurred around scope validation of the      |
|            | projects and applications that fall under the purview   |
|            | of this SIG. The various projects and tools include     |
|            | Study Initiation Tool, DCP Enterprise System            |
|            | Knowledgebase, Protocol Lifecycle Tracking System,      |
|            | Investigator and Site Credential Repository, and        |
|            | FIREBIRD. Identifying the clinical trial business       |
|            | process was seen as a key activity that will need to    |
|            | occur so that the functionalities of the various tools  |
|            | can be mapped more clearly. Requirements for some of    |
|            | these tools were identified. Investigation of currently |
|            | existing tools at various institutions or commercial    |
|            | systems should be done to check if one of these systems |
|            | could be adapted to meet the planning/ monitoring       |
|            | requirements of the NCI community. Various DSIC         |
|            | policies relevant to data sharing based on the current  |
|            | scoping of these tools were conducted.                  |
+------------+---------------------------------------------------------+
| Discussion | -   John Speakman presented an overview of the          |
|            |     Planning/ Monitoring SIG in terms of its goal and   |
|            |     the various projects that fall under this SIG. His  |
|            |     presentation is available at                        |
|            |     <https://cabig.                                     |
|            | nci.nih.gov/workspaces/CTMS/CTMS_Face_to_Face_Meetings> |
|            |                                                         |
|            | -   The Goal of the SIG is to facilitate the            |
|            |     [planning]{.underline} and instantiation of         |
|            |     clinical trials, (and their                         |
|            |     [monitoring]{.underline} of trials once they are    |
|            |     instantiated)                                       |
|            |                                                         |
|            | -   The various projects/ applications that fall under  |
|            |     this SIG are:                                       |
|            |                                                         |
|            | 1.  Study Initiation Tool                               |
|            |                                                         |
|            | 2.  DCP Enterprise System Knowledgebase (DCP/DESK)      |
|            |                                                         |
|            | 3.  Protocol Lifecycle Tracking                         |
|            |                                                         |
|            | 4.  Investigator and Site Credential Repository         |
|            |                                                         |
|            | 5.  FIREBIRD                                            |
|            |                                                         |
|            | -   The SIG discussed each of the applications in       |
|            |     detail either to identify the scope and/or validate |
|            |     the scope.                                          |
|            |                                                         |
|            | **Study Initiation Tool (SIT)**                         |
|            |                                                         |
|            | -   SIT is a tool that was recommended by the Clinical  |
|            |     Trials Working Group (CTWG) and is an NCI           |
|            |     initiative. As per the CTWG Report[^1], the SIT     |
|            |     would be a web-based trial initiation portal to     |
|            |     facilitate phase III treatment and complex phase II |
|            |     protocol activation at sites. The functionality     |
|            |     will be similar to the trial initiation materials   |
|            |     provided to sites by industry sponsors and will     |
|            |     include a checklist that reminds sites of staff and |
|            |     services that must be in place to successfully      |
|            |     implement a trial (e.g., personnel requirements,    |
|            |     necessary infrastructure, IRB submission            |
|            |     requirements, data management needs, procedure      |
|            |     instructions, etc.).                                |
|            |                                                         |
|            | -   The target users of the SIT must be identified:     |
|            |     cancer centers, smaller institutions or both?       |
|            |                                                         |
|            | -   We need to identify the functionality requirements  |
|            |     of the Tool (the "what"), not the implementation    |
|            |     aspects (the "how").                                |
|            |                                                         |
|            | -   What are the desired functionalities of SIT?        |
|            |                                                         |
|            | ```{=html}                                              |
|            | <!-- -->                                                |
|            | ```                                                     |
|            | -   SIT will include more than"checklist"               |
|            |     functionality, although this is one of the features |
|            |     which would either interface with other systems     |
|            |     from sponsors and trial sites or be integrated into |
|            |     the local CTMS systems so that the status of trial  |
|            |     initiation process and missing documents/           |
|            |     approvals, etc, can be identified.                  |
|            |                                                         |
|            | -   Data sharing, informed consent process, and trial   |
|            |     resource list are also functional features that we  |
|            |     may want to consider.                               |
|            |                                                         |
|            | -   It could act as a complete electronic replacement   |
|            |     for paper                                           |
|            |                                                         |
|            | -   SIT will need to be interoperable with other        |
|            |     systems, including the Clinical Trial Database.     |
|            |                                                         |
|            | -   Whether SIT will support investigator initiated     |
|            |     trials is an issue that will need to be considered. |
|            |                                                         |
|            | -   The scope of SIT in terms of clinical trial phases, |
|            |     types of trials (drug trials / device trials /      |
|            |     both) will need to be addressed.                    |
|            |                                                         |
|            | -   The CTWG report lists Phase II and III but should   |
|            |     SIT be limited to just those? Are there specific    |
|            |     requirements in initiating different phases of      |
|            |     trials? We will need to check with CTEP and DCP to  |
|            |     get clarity on this. Also, since the demarcation    |
|            |     between Phases are becoming less distinct (example: |
|            |     now there are Phase 0/I, Phase I/II), it would be   |
|            |     better to include all phases of trials?             |
|            |                                                         |
|            | -   Identify dependencies between SIT and other         |
|            |     applications - could FIREBIRD feed the SIT          |
|            |     checklist?                                          |
|            |                                                         |
|            | -   Identify other SIT-like tools to identify potential |
|            |     functional behaviors.                               |
|            |                                                         |
|            | -   Scope of SIT will be better addressed when the      |
|            |     project is established and a Vision and Scope       |
|            |     document is developed and vetted with the           |
|            |     community. This will address the components of the  |
|            |     clinical trials process that the SIT will           |
|            |     encompass. One approach regarding the clinical      |
|            |     trials process that was suggested is to leverage    |
|            |     Pharma and Biotech process, distill aspects of the  |
|            |     process that is essential and relevant and then     |
|            |     synthesize the requirements. Once we have a list of |
|            |     requirements, we can validate it with CTEP and DCP. |
|            |                                                         |
|            | **DCP Enterprise System Knowledgebase (DESK)**          |
|            |                                                         |
|            | -   DESK is a set of web-enabled systems to support the |
|            |     scientific and administrative work of the NCI       |
|            |     Division of Cancer Prevention (DCP). DESK is also a |
|            |     way to standardize data across clinical trials and  |
|            |     distribute information to DCP and its contractors.  |
|            |                                                         |
|            | -   It includes a DCP internal database that tracks a   |
|            |     protocol from submission to approval. It covers the |
|            |     whole lifecycle of a study and a protocol document. |
|            |                                                         |
|            | **Protocol Lifecycle Tracking (PLT)**                   |
|            |                                                         |
|            | -   The Protocol Lifecycle Tracking Tool will assist in |
|            |     managing and documenting a protocol through the     |
|            |     entire life cycle of the trial, starting at Concept |
|            |     Development and continuing through to the end of    |
|            |     the cycle with Submissions and Publications.        |
|            |                                                         |
|            | -   Various storyboards were presented that would       |
|            |     enable different stakeholders to use the PLT system |
|            |     to track a protocol through its life cycle.         |
|            |                                                         |
|            | ```{=html}                                              |
|            | <!-- -->                                                |
|            | ```                                                     |
|            | -   Investigators could model workflows and develop a   |
|            |     configurable decision tree for protocol development |
|            |                                                         |
|            | -   Institutional leadership could use it as a          |
|            |     high-level dashboard to view the status of pending  |
|            |     and approved protocols.                             |
|            |                                                         |
|            | ```{=html}                                              |
|            | <!-- -->                                                |
|            | ```                                                     |
|            | -   It should be built so that it will be user friendly |
|            |     and should be capable of capturing exceptions.      |
|            |                                                         |
|            | -   This system has to be very granular in terms of the |
|            |     data that will be included.                         |
|            |                                                         |
|            | -   We might consider investigating existing systems    |
|            |     that may provide this functionality (e.g., Velos    |
|            |     was suggested by the University of Michigan).       |
|            |                                                         |
|            | **Investigator and Site Credentials Repository (ISCR)** |
|            |                                                         |
|            | -   The ISCR will be a credentialing system for         |
|            |     clinical trial investigators and sites that is      |
|            |     recognized and accepted by NCI, industry sponsors,  |
|            |     clinical investigators, and clinical trial sites.   |
|            |                                                         |
|            | -   This system will be a credentials repository, as    |
|            |     opposed to a system that will credential            |
|            |     investigators or sites.                             |
|            |                                                         |
|            | -   Existing systems to be potentially considered for   |
|            |     the basis of such a system include FIREBIRD and the |
|            |     Clinical Trial Support Unit's Regulatory Support    |
|            |     System (RSS). FIREBIRD currently submits            |
|            |     credentials (Form 1572) to FDA; RSS supports the    |
|            |     IRB process but is not set up to interoperate with  |
|            |     DESK.                                               |
|            |                                                         |
|            | -   It can be envisioned that the ISC (credential       |
|            |     repository) will feed into FIREBIRD (for submission |
|            |     to FDA).                                            |
|            |                                                         |
|            | **FIREBIRD**                                            |
|            |                                                         |
|            | -   FIREBIRD (Federal Investigator Registry of          |
|            |     Biomedical Information Research Data) automates the |
|            |     Form 1572 registration process, a key activity in   |
|            |     the regulatory data submission process and          |
|            |     compliance requirement for investigators            |
|            |     participating in clinical trials.                   |
|            |                                                         |
|            | -   We will want to consider FIREBIRD to have the       |
|            |     functionality of submission of investigator and     |
|            |     site documents for trials that don't require Form   |
|            |     1572 (example- medical devices trials).             |
|            |                                                         |
|            | **DSIC Policies Relevant to Planning/ Monitoring        |
|            | Tools**                                                 |
|            |                                                         |
|            | -   Elaine Brock from the DSIC Workspace facilitated    |
|            |     the discussion on what data sharing policies are    |
|            |     applicable to the tools under the Planning /        |
|            |     Monitoring SIG.                                     |
|            |                                                         |
|            | -   The policies centered around Intellectual Property  |
|            |     (IP) value, data sensitivity, Institutional Review  |
|            |     Board (IRB) restrictions, and sponsor restrictions, |
|            |     and the policies were categorized based on high,    |
|            |     medium, and low impact based on the DSIC Decision   |
|            |     Tree for Privacy/ Intellectual Capital Terms and    |
|            |     Conditions.                                         |
|            |                                                         |
|            | -   For purposes of this discussion, it was decided     |
|            |     that FIREBIRD functionalities overlap with those of |
|            |     ISCR and DESK functionality overlaps with that of   |
|            |     PLT, so the DSIC considerations are generally       |
|            |     equivalent.                                         |
|            |                                                         |
|            | The various policies relevant to each of the tools were |
|            | identified and are available in the detailed Planning/  |
|            | Monitoring SIG Report-Out presentation located with the |
|            | materials from the May 2007 CTMS Face to Face meeting   |
|            | on the caBIG website.                                   |
+------------+---------------------------------------------------------+
| Re         | +---------+-----------------------------------------+   |
| quirements | | **Requ  | **Description**                         |   |
|            | | irement |                                         |   |
|            | | ID**    |                                         |   |
|            | +---------+-----------------------------------------+   |
|            | | PM 1    | SIT will support all clinical trial     |   |
|            | |         | activities until "open to accrual".     |   |
|            | | PM 2    |                                         |   |
|            | |         | PLT will manage and document a protocol |   |
|            | |         | through the entire life cycle of the    |   |
|            | |         | trial, starting at Concept Development  |   |
|            | |         | and continuing through to the end of    |   |
|            | |         | the cycle with Submissions and          |   |
|            | |         | Publications.                           |   |
|            | +---------+-----------------------------------------+   |
+------------+---------------------------------------------------------+
| **Issues** | #### Identifying                                        |
|            |  the clinical trial business process was seen as a key  |
|            | activity that will need to occur so that the functional |
|            | ities of the various tools can be mapped more clearly.  |
+------------+---------------------------------------------------------+
| Action     | +--------+---------------------------------+-------+    |
| Items      | | ####   | #### Description                | ###   |    |
|            | |  Assig |                                 | # Due |    |
|            | | ned To |                                 |  Date |    |
|            | +--------+---------------------------------+-------+    |
|            | | ####   | ####  Review CTEP and DCP       | ####  |    |
|            | |        | clinical trial business process |       |    |
|            | |        |  to identify a common workflow. |       |    |
|            | |        |                                 |       |    |
|            | |        | ####  For identifying           |       |    |
|            | |        | the requirements for SIT, colle |       |    |
|            | |        | ct examples of check list and o |       |    |
|            | |        | ther functionalities from Pharm |       |    |
|            | |        | a/ Biotech, U.S. Army, VA, etc. |       |    |
|            | |        |                                 |       |    |
|            | |        | ####  Invest                    |       |    |
|            | |        | igate institutions (University  |       |    |
|            | |        | of Michigan, University of Dart |       |    |
|            | |        | mouth, University of New Mexico |       |    |
|            | |        | ) that have systems that have f |       |    |
|            | |        | unctionalities required in PLT. |       |    |
|            | +--------+---------------------------------+-------+    |
+------------+---------------------------------------------------------+
| Next Steps | 1.  Identify the business process for the entire        |
|            |     clinical trial and map the various tools that       |
|            |     support Planning/ Monitoring to specific            |
|            |     activities. When identifying the sequence of the    |
|            |     activities, we need to ensure that we specify which |
|            |     activities are in lock-step sequence, which are in  |
|            |     parallel, and which can be out of sequence (or      |
|            |     flip-flopped). The business process should include  |
|            |     three levels- managing the study, managing the      |
|            |     data, managing participants.                        |
|            |                                                         |
|            | 2.  Identify open source workflow tools that can be     |
|            |     modified or adapted to meet the needs of the NCI    |
|            |     community in terms of planning and monitoring a     |
|            |     trial.                                              |
+------------+---------------------------------------------------------+
| Attendees  | +---+--------+-----------+--------------------------+   |
|            | |   | **Last | **First   | **AFFILIATION**          |   |
|            | |   | Name** | Name**    |                          |   |
|            | +===+========+===========+==========================+   |
|            | | 1 | Brock  | Elaine    | University of Michigan   |   |
|            | | . |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 2 | Budd   | Troy      | NCI/Division of Cancer   |   |
|            | | . |        |           | Prevention               |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 3 | C      | Deborah   | Patient Advocates In     |   |
|            | | . | ollyar |           | Research (PAIR)          |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 4 | Co     | Paul      | Dartmouth/Norris Cotton  |   |
|            | | . | urtney |           | Cancer Center            |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 5 | F      | Doug      | University of Pittsburgh |   |
|            | | . | ridsma |           |                          |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 6 | Fr     | Steven    | Cancer Therapy           |   |
|            | | . | iedman |           | Evaluation Program, NCI  |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 7 | Jones  | Dennie    | University of New Mexico |   |
|            | | . |        |           | Cancer Research and      |   |
|            | |   |        |           | Treatment Center         |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 8 | Joyce  | Niland    | City of Hope National    |   |
|            | | . |        |           | Medical Center           |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 9 | Kaefer | Christine | NCI Center for           |   |
|            | | . |        |           | Bioinformatics           |   |
|            | |   |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 1 | Loose  | David     | BLCPro                   |   |
|            | | 0 |        |           |                          |   |
|            | | . |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 1 | R      | Diane     | Booz Allen Hamilton      |   |
|            | | 1 | ickman |           |                          |   |
|            | | . |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 1 | Sp     | John      | NCI Center for           |   |
|            | | 2 | eakman |           | Bioinformatics           |   |
|            | | . |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
|            | | 1 | Va     | Susan     | Booz Allen Hamilton      |   |
|            | | 3 | rghese |           |                          |   |
|            | | . |        |           |                          |   |
|            | |   |        |           |                          |   |
|            | +---+--------+-----------+--------------------------+   |
+------------+---------------------------------------------------------+

[^1]: <http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf>