Transcript Slide 1

DATABASE MANAGEMENT PI
SURVEY RESULTS
What are your biggest concerns about data
management for your research protocols?
I do think data managers need better managers than just PIs--ideally masters or PhD level biostatisticians
who can make sure they are doing things correctly.
Lack of interoperability our various data repositories. Administrative overhead inhibiting projects. Lack of
interest in supporting research applications of data mining projects (compared to financial management and
clinical support resources).
Integrity Longevity Completeness Security Access (no pun intended) to the data
So far, with mostly chart review projects, only simple databases have been necesary, for which no dedicated
manager has been needed.
it is a very expensive undertaking. If there were a centralized source it might help to cut down on costs
Managers for hire do not have content expertise We need a uniform system integrating data collection into
databasing
Consistency with turnover of data management staff
Stability over time Ease of access
Correct entry of data, correct interpretation of clinical events as it is entered into the database.
That i do not adequately utilize the managers, and that they might enter data without recognizing it is
incorrect.
JHU HR payscale is very low compared to what these positions would be paid in the private sector, making it
very difficult to compete for top quality candidates. Servers that house our data are managed by folks who do
not fully appreciate the importance of data integrity and data security. Our data our housed on three
different servers and they all have different policies for backing up data, some only saving data back to six
weeks. More sophisticated IT support would be helpful. The resources needed to support a data core on an
ongoing basis are enormous and would take up a very large chunk of typical NIH/foundation grant budgets.
This makes fundraising challenging for a data core.
maintaining searchability by discrete elements of data vs. narratives that are not searchable; inability to "cross
populate" data from other databases, necessitating transcription of data already available, which is both time
consuming and error prone.
Data systems within JHU/JHH do not interface. Licenses for software held by JHM,run over the internet are not
kept up to date, such as SPSS.There are days to weeks when databases are not available because of this issue.
Data entry errors and lack of knowledge of program
Ability to get data base management assistance for preliminary data and without funding for a person to assist. I
want to use RedCap and don't have the resources to use that data base. If my grant is funded my collaborator
has free access to it. I would like to see this database recieve IT support via the ICTR.
insufficient experience
Continued access to highly skilled personnel for high level data management/database modification and
programming.
Audit trail robust relational database
There is no financial, human or computer resouces that I can access to adequately construct a fully functional
21st century clinical database within my control.
Finding people to design a database and how to pay them for periodic adjustments changes to the database.
Finding one willing to work on a project part-time or institutionally reported.
My studies are relatively small at present and I feel I can manage the data myself using SPSS. That said, I also
have little choice in the matter given the unfunded nature of the work right now.
Lack of additional training opportunities.
I have not used databases for my research so far.
Access to data mangers and timeliness of reports.
Merging of data from multiple institutions
I don't even know the resources available for data management so I do it myself.
The new expectations that our databases need to be compatible with CaBig, CaTissue etc.
That the data are entered accurately, and that the data base manager is double checking his/her work.
Identifying qualified data managers. We have a superb one now.
I would be lost if i ever lost the person I now have. As my answers to questions 7 and 8 show, I am very lucky to have
the person I have (who was actually hired by my then-project director over 10 years ago). If i had to replace her, I'm
not sure I would know how to begin. Not only does she do a fantastic job on our research, she teaches our post-docs
about data management. She does all of this long-distance, as she has lived in western Pennsylvania for the past 5
years. Therefore, any new ICTR opportunities for networking/training would need to take this into account.
It would be great if I had sufficient funds to have one person dedicated to data management! I can't imagine a
universe with this type of luxury.
Inability to monitor accuracy due to time constraints
Data security and integrity
I am very interested in meeting with other data managers. I have a strong technical background, but no experience in
research, and would really appreciate a network of people with whom I could trade information and experience.
Currently doing it all myself. Concern for completeness of data acquisition given time constraints, etc.
Data entry errors, formatting of data entered so that data could be used for biostatistical analyses.
Availability of trained personnel. Hard to believe there's an employment crisis in the US. Plenty of data coordination,
data QA, and regulatory-compliance positions to go around!
There are not enough database managers who are available contractually to help with development and running
data for trials. This requires dedication and detail oriented people who are often hard to find. Department budgets
don't usually have the money to support their own data manager.
insufficient interface with/access to GI tissue bank and database
Making sure that data is not lost when program encounters errors (File-maker PRO data base).
It was difficult to answer question 3 above, as we are part of two national consortia, with some data management
here and some by the data coordinating center at Mass General Hospital. My biggest local concern is our general lack
of easily accessible tools to quality check data entry. I am fortunate to have careful individuals working on our data
collection.
Turnover of personnel who control. Proper backup of information. Procedures to minimize data entry errors.
Any potential violations of privacy
managers maintaining skills IT support lacking knowledge to adequatley supervise of data managers
Support for web-based surveys-- we had a hard time identifying who to call and then uploading it to the
surver. We could use more support in this area. Ensuring that databases are built correctly to ensure that data
is accurately captured and easy to clean and manipulate for analyses. This is particularly true for data directly
imputed by patients. Would like to move into audio CASI, but don't have the staff or resources to do so.
Important since we work with low-literacy participants.
We need to create the database from paper source documents. Dr. Diener-West will assist us in the selection
and supervision of the candidate.
I have been careful about hiring competent data managers and working to retain them. The best are too easily
hired by local pharmaceutical companies or CRO's, who can pay 2-3 times in salary and bonuses what we pay.
Quality of the data captured
continuity; position turnover can be an issue
I have no main concerns. A minor issue is making sure the data are entered in a format that can easily be read
by a statistical software package.
I do not currently have a database as part of my research protocol
advance programming to extract and organize data for analysis
efficiency
It is a time-consuming role that is vastly under-estimated and under-funded by NIH. There is little training, at
the JHU institutional level, regarding data management and quality assurance issues for investigators and
research staff -we "invented the wheel" to create our own systems, but there may have been more efficient
ways that we could have learned along the way.
1. Security. 2. Loss of data 3. Lack of access to data
My only concern is that the current process will pull my data management staff away from current work, and have
them attending something else that becomes a mandatory training, etc., by the university.
I am very happy with the employees who have been doing our database management. Honestly the biggest concern
is trying to piece together funding to continue to support them while the grant funding is reduced. I have a great
employee who has been working with our group for more than 10 years, and I may have to let him go soon if we can't
find some additional funding for him.
I think it's been great so far. I'm a little worried about problems with my statistician not being able to access the
database, but we're working on that.
We do not have established SOPs for data management and each study seems to be reinventing the wheel. Given the
integration of data management with QA issues, this is critical issue as it impacts data quality.
My next grant attempt involves a much larger data field. At that time, I do anticipate using a manager to monitor my
data. To date, I have not needed a database manager.
Being able to find good technical assistance. As I am not fulltime reserach nor NIH-funded, I rely on exisiting divisional
resources or paying a la carte for data management/statistical support needed for my studies.
Funding
not a stanrade process..we worked with two different groups for our very small project before we decided to do it
ourselves. first was solo contractor...she did not do the work in a timely fashion, second was a group from an external
university in mid west (i dont know theier names) they also ran out of steam, became unresponsive to our needs for
skip patterns that worked in teh questionaire we diesigned and we terminated that agreement. WE now use a Survey
monkey product for data collection and excell and SPSSS to analyze data.
My own limited training in this area and need to rely on colleagues.
If I ever get funding for my own independent research, I do not know who will manage the database. It would be nice
to have a pool of available database managers for protocols for whom salary support could be provided in grant
applications which might help with obtaining funding.
The lack of centralized and consistant HIPAA compliant database development and management for investigator
initiated trials
Intergration of database management and statistical analysis.
1) Being able to support a sufficient level of effort to get the task done. 2) Being able to get biostatistics
consultation for the database manager to maximize the efficiency of the system.
understanding social science research and data needs for project determining skill level
Lack of oversight
the learning curve the payscale and ability to move up some are lifers - others use job as stepping stone - so turnover can be a concern
Lack of resources for quality control of data quality
database crashes missing data missing datafields difficulty with search items not forseen
We are fortunate to have an extremely competent database manager, so at this time, I have no concerns.
Our data volumes are enormous and it will pretty soon become difficult for single groups to keep them at a high
level
Not enough time to do myself and not enough resources to hire anyone else.
Quality COntrol
access to the data routine QC of data entered
1. How to ensure the data are entered accurately, up to date, and clean/ready for analysis. 2. How to export data
from Access and import it into SPSS. 3. Need for more dynamic data entry system (e.g., REDCap) and folks with
expertise in that system to assist. 4. Need for an efficient data management system to do tasks such as
combining distinct datasets that have common data elements.
It would be helpful to have educational sessions on how to assess database managers, supervise them, as well
as support to improve their skills through educational opportunities. Thank you.
Not a problem for me: large-scale work done by coordinating centers; small-scale work done by junior faculty,
fellows, and students who work with me, all of whom have a least masters level training in epidmeiology,
including some database experience.
Need more consistent quality control measures
Lack of training Lack of database development support from the ICTR
Mistake during data entry.
Accuracy of the data that is put into the database. Ability to employ someone that can put data into the system.
Understand the importance to complete the data entering and monitoring in a timely fashion - within a couple
of days of data collection
quality of data collection and management at overseas sites
I have no concerns since data management for our research protocols are managed by our sponsors and they
seem to do an excellent job managing our data.
Ability to anticipate future needs Ability of platform to last for years (eg will I be able to retreive this data 20
years from now?) Ability to store imaging studies
organization of data
Data organization and storage
My biggest concern is that someone takes the data from JHH email system.
Clinical knowledge of the speciality being studied. Reliability measures for the data. Flexibility within collection
process for future data. Error rate.
I have none and am quite comfortable with the analysts at UWash.
Losing current staff and needing to replace them.
Developing stratagies that will ensure that we are collecting the most valuable data.
Data verification Privacy
Majority of data management I have done has been with fellows.
No supervision by data mgt mavens; no community; no opportunity to advance. Thus, best and brightest don't want
to work here.
My lack of experience.
Managing diverse types of data
It has been difficult to identify a data manager with adequate data management skills since my study budget does
not allow for a FT data manager. Also, there seems to be limited sharing of "best practices" for data management.
compliance to IRb protocol
- Difficulty in obtaining timely, accurate follow-up data - Multiplicity of systems at JHMI that don't talk to each other
- Inability to readily and securely link to data from JHMI clinical databases, and to extract information from free text
in medical records - Difficult to fund an individual just to be a database manager, so they tend to have other
responsibilities that can distract them - Database managers need more opportunities for advancement and staying
abreast of latest technologies
Multiple clinical systems for source documents make it difficult to appropriately and accurately gather data,
especially in a short time window, as is often required by sponsors. Similarly, CRFs are not standardized, and I feel
these varied reporting systems increase the chance of error and delay in data management
The lack of specialization and training in this important area. Essentially these people learn through trial and error,
become highly competent at a single system, and show little ability (generally) to work across systems. The lack of a
unified approach through the SOM does not help.
I do not conduct research at this point in time; the studies I do conduct are educational in nature and do not
generate a database that requires a manager
Use of Access for data management without good tracking of modifications of the data
back up
Following protocols exactly as specified, collecting all necessary data, recruiting, etc
Center for Clinical Trials is competent but startup time is very long and this delay is very costly to the trials I am
working on. Frankly I'd like to develop our own local competency and drop them.
None to mention, My projects are relatively small and I have some basic data management skills.
None
I don't have any concerns now that I have hired this person. That said, I am completely dependent upon his expertise.
Integrety of data; preventing inadvertent and untraceable changes; increasing knowledge of senior colleagues who
think they understand database needs/requirements from imposing their ideas on staff.... data security writing
adequate sections in grant applications about attending to database oversight
Lack of adequate funds for a data manager
No concerns.
data integrity
Accuracy Statistical analysis
none at this time
Time is the most critical element and it would be a major support to have someone assist with database
management.
adquate medical knowledge
consistency, ease of use and robustness to meet individual needs
I have managed the data for my protocols. This might change with my new RO1 grant.
That they are performed accurately.
IRB and protocol compliance
Our biggest concern about data management is how to support/pay for this person?
Need help developing better databases which allow for research and meeting requirements for monitoring patients
and reporting AE's.
That I haven't paid enough attention to data management. I am hoping to use RedCap in the future which should help
with some structural issues
support
I am highly dependent on the managers with whom I work and if they were ever to leave JHU I would have difficulty
replacing them. A centralized service would likely work better. However, there are smaller projects with limited
funding (at least early on) that require some database management input and if the service were too expensive these
might not be viable.