Please read and critically appraise the attached Data Management plan according to the criteria below. Using this document, please type your answers below each item. I am looking for short, succinct answers to these questions. When you have finished, save the document with the following file name: HCR562 EXAM (your last name) and email it to me.
INTRODUCTION:
Were the aims and purpose of the study clearly stated? ( provide more than just yes or no)
Not really. First of all, this data management plan (DMP) was not developed for a study, but rather to detail the Melbourne Neuropsychiatry Centre’s (MNC) IT plans for expanding their laboratories and management resources to support research. The focus of the DMP was not explained until page 5, and an overview of their bioinformatics project was not detailed until the very end.
Briefly summarize the aims and purpose of the study and who you think the intended audience is for the data management plan.
Again, this is not a study, but a project. The Bioinformatics Development Project at MNC has three goals: (1) to organize data into one central database, (2) curate data for long-term preservation and management of the data, and (3) provide access to allow search of the dataset with complex queries.
The intended audience for the DMP includes management, the researchers of the five respective streams of specialty at MNC, and all major stakeholders.
ETHICAL ISSUES:
What are the ethical and privacy issues associated with this study?
The data to be managed include cognitive, neuroimaging and bio and neuroinformatics patient data. Although these data contains confidential patient information, the information is gathered in the process of the clinical management of these disorders. There are no ethical issues associated with the project as the project deals with a system for the storage and retrieval of data supported by sophisticated security applications and not with the gathering of data. However, the entry of old data now stored in SPSS spreadsheets into the MNC database may represent an ethical problem as patient data will be read by others without patient authorization.
What steps have been taken to safeguard/protect participants and data?
Some of the data include MR Images and these are all encoded according to a master code. The master code is secured with the Neuroimaging Research Assistant responsible for the coding of MRI data onto the database. The IT and Imaging Laboratory Manager can also access the code for security reasons. Non-neuroimaging data is also secured by a master code. There is no information regarding the safeguarding of participants as this is not a clinical study.
ACCESS & DATA SHARING:
How will data be made available?
The MNC database development includes a front-end GUI (general user interface). The access and authentication requirements of the GUI include authentication, authorization, and administration safeguards. The data will be made available to any user that can prove authentication and authorization.
What is the process for gaining access?
User Login users must provide a password and have limited access. Administrators have the authority to view and query all data, and to grant permission to access certain data. Administrators have the power to add new users or deny access to the system.
Are there any permissions/restrictions placed on the data?
Specific permission is required to access data in particular tables and particular fields. Tables and fields will be hidden from any user which ahs not been granted special permission.
Will the data be shared and if so, what is the process for sharing?
It is critical for researchers to be able to share data with their collaborators and research assistants, as well as with research students. Data can be shared through the granting of access to certain tables and data fields.
DATA COLLECTION
What data are being collected for this study?
Two major categories of data are being collected: neuroimaging data and non-neuroimaging data. But these data are not for “this study.” That data will consist of data collected in MNC research studies. In addition, there will be administrative data being collected.
Describe how are the data being collected (include instruments, methods, formats).
The MNC collects data from a variety of sources and in different formats/medium depending on the
type of research project. Subject data is collected by pen/paper then transferred to an electronic medium. MR Image Information is in the form of an electronic data file. Other electronic data include derived MRI data and data volumes. Blood tests, clinical data, neuropsychological data, and cognition and behavioral data are all paper report and electronic data. Responsibility for these data mainly rests on the clinical research assistants.
How are data verified?
The MNC Bioinformatics Research Fellow has developed tools to integrate the current and legacy SPSS
spreadsheets and the MNC database using Python scripts. These tools serve to validate data in different versions of SPSS spreadsheets.
How are discrepancies/corrections to the data handled and documented?
No precise information is given as to how discrepancies and corrections to the data are to be handled and documented. However, the system has a tool for double entry results to reach data integrity.
SHORT-TERM DATA STORAGE & MANAGEMENT
Where will the data be stored?
MNC stores data in various formats and locations. Neuroimaging data, and raw MRI data on media is stored is stored electronically on central secured file systems within the Neuropsychiatry Imaging Laboratory. Non-neuroimaging data is now stored by the researcher in charge of the research project. Data will later be stored in the MNC system.
On what media?
Data will be stored in electronic media.
Who will be responsible for managing this task?
The Clinical Research Assistant RA, the Neuroimaging RA, Research Fellows, students and researchers are all responsible for data management.
How will it be transmitted?
Data will be transmitted electronically.
How is access and data security managed?
The Neuroimaging Research Assistant, the IT and Imaging Laboratory Manager all have access and are responsible for data security. The administrator assigns access to rights.
How frequently are the data backed up and who performs this task?
The IT and Laboratory Manager back up all the data every fortnight. In addition, every six months there is an offsite archival of all the data.
COMPLIANCE & REVIEW
Is there a plan for monitoring adherence to the Data Management Plan? If so, describe how this will be done and how frequently. If not, suggest a monitoring and review timetable and who would be responsible for carrying out this review.
The Bioinformatics Research Fellow is in charge of overall QA/QC of all data managed. Research fellows oversee data entry. The neuroimaging RA is in charge of QA/QC of MRI data and the IT & Imaging Lab Manager oversees data summary and reporting. All these duties serve to monitor adherence to the DMP, especially since there appears to be a certain degree of overlap in the overseeing and management of data.
