Do You Have a Team?

A team is a group of individuals who see themselves and are seen by others as a social entity, which is interdependent because of the tasks performed as members of a group.

Not every member works well together. We have team members that are passive-aggressive, others that do not participate and do not turn in their assigned task. However, we can bring out either the best or worst in one another.

When a group of individuals work together to achieve a goal, they often fail because individual agendas outweigh the commitment to the common goal.

In some companies, team members are provided with a great deal of feedback regarding their performance, they are encouraged to work for the common good of the organization. But there are also team members that do not understand the decisions that are made, or don’t agree with them.

Teams do not become effective overnight. Team building is a process that requires due attention and care. Team development means developing a person’s skills both within the group and individually, for the goal of enhancing project performance. Development as a team is critical to project success.

To be able to work independently, the team member must be creative, proactive and inspired by a vision of how things could be. At the same time the individual must be accountable for each task even if they have a team to do the work. I work from home and many of my team members live across the country. We meet once a week and we have access to email. As part of a Virtual Team Member, I must be able to stay focused to get things done.

anayansi gamboa team building

If a team member does not perform up to standards, for example, if he/she does not return a task on time when promised and does not advise the reason, the project team contacts them. If the member responds and asks for an extension, he/she is advised who will make a decision as to whether the member should be granted an extension. If at the end, there is no response, the project manager will make a decision as to whether the team member should be removed.

If we keep on doing what we’re doing and working as one team, the project will be a success.

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)


Team Collaboration and Conflict

Conflict is inevitable and can be positive. Sometimes the person who disagrees actually does have a better way. Conflict is a natural result of change, but to manage it properly, we must focus on the facts, not the emotions. In other words; focus on the problem, not the person.

Ineffective team collaboration is one of the primary contributors to costly rework and delivery failure in many projects. Team collaboration is about sharing knowledge and reaching consensus within the team.

‘Problem-Solving Teams: Quality Circles’. I personally never read an article related to ‘conflict and team members with Quality Circles’ but they primary goal to foster an exchange of ideas and the use of basic tools such as brainstorming, checklists and Pareto chart, etc. were very familiar to me.

First, we should understand the major sources of conflict for a project. For instance, at the beginning of a project, project priorities, administrative procedures and schedules are the main sources of conflict. Towards the middle and end of a project, schedules create the most conflict, followed by resources, and technical issues. Personality conflicts are lower of the list, as are cost.

After we have clear understanding of what are the conflict and the sources, we can work on resolving those conflicts. Confronting the problem head-on without being confrontational towards the person is the best win-win situation. We examine alternatives with an open mind, and really agree on the best solution.

Ideally we want to build a positive relationship with positive statements all along. If you include a positive statement at the same time you address the problem, focus on the issue and be specific. For example, “I know it is not your fault but I trust that as a good team player, you will be here from now on.”

anayansi gamboa conflicts

In order to smooth the progress of conflict resolution, we should obtain feedback during the meeting and status reports; stress to the team and customer how critical it is to communicate any issues during the status meetings or at least to the project manager. Provide an explanation with the updated information.

Many projects do not deliver, and get canceled before they are completed. Team collaboration issues are very often the reason why projects fail, but if the right infrastructure is available to facilitate effective knowledge sharing among the team members, conflict will be minimize.

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)


Project Plan: CDISC Implementation

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle – from planning, through execution, to completion.

1) Define Scope: This is where you’re tested on everything that has to do with getting a project up and running: what’s in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you’re delivering matches what you wrote down in the scope statement.

2) Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

Project Tasks  (Work packages) Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3) Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few. A sample of the project plan is shown below:

project plan sample
image from Meta‐Xceed paper about CDISC

4) Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project. The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also  due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in:  ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

test plan-cdisc

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project. riskplan

5) Transformation Specification: Dataset transformation is a process in which a set of source datasets and its variables are changed to  meet new standard requirements. Some changes will occur during this step: For example, variable name must be 8 chars long. The variable label must not be more than 40 chars in length. Combining values from multiple sources (datasets) into on variable.

6) Applying Transformation: This is done according to specification however, this document is active during the duration of a project and can change. There are now many tools available to help with this tasks as it could be time consuming and resource intensive to update the source code (SAS) manually. Transdata, CDISCXpres, SAS CDIDefine-it; just to name a few.

7) Verification Reports: The validation test plan will detail the specific test cases that need to be implemented  to ensure quality of the transformation. For example, a common report is the “Duplicate Variable” report.

8) Special Purpose Domain: CDISC has several special purpose domains: CO (comments), RELREC (related records or relationship between two datasets) and SUPPQUAL (supplemental qualifiers for non-standards variables).

9) Data Definition Documentation: In order to understand what all the variables are and how they are derived, we need a annotation document. This is the document that will be included during data submission. SAS PROC CONTENTS can help in the generation of this type of metadata documentation. The last step in the project plan for CDISC implementation is to generate the documentation in either PDF  or XML format.

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.