Introduction to Clinical Data
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Clinical data is either collected during the course of ongoing patient care or as part of a formal clinical trial program. Funding agencies, publishers, and research communities are increasingly encouraging researchers to share data, while respecting Institutional Review Board (IRB) and federal restrictions against disclosing identifiers of human subjects.
You should take initial steps to de-identifydata for:
- Protectingdata during research projects
- Preparingdata for vetted collaborators, restricted-access or public accessdata repositories
Clinical Data Terminology
- Personal Identifiers Private information that subjects expect not to be made public that are linked to information associated with a unique individual
PII: Personally Identifiable Information(NIST SP- 800-122)
- Any information maintained by an agency…used to distinguish or trace an individual’s identity
- Any other information that is linked or linkable to an individual
PHI:Protected Health Information- Created or received by a health care provider
- Relating to physical or mental health of an individual or provision of care (past, present, or future) and (i) that identifies or (ii) could be used to identify the individual. (HIPAA's Privacy Rule)
- Types of Identifying Information Identifying information is classified as one of two types: direct and indirect
Direct Identifiers:HIPAA lists 18 typical direct identifiers for PHI as part of the standards for patient protection used by US Health and Human Services.
- Names
- All geographic subdivisions smaller than state, including street address, city county, precinct, zip code and theirequivalent geocodes, except for the initial three digits of the ZIP code if: the geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and the initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people is changed to 000
- All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
- Telephone numbers
- Fax numbers
- Email address
- Social Security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate or license numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Web Universal Resource Locators (URLs)
- Internet Protocol (IP) addresses
- Biometric identifiers, including finger and voice prints
- Full-face photographs and any comparable images- photographs are not limited to images of the face
- Any other unique identifying number, characteristic, or codethat could uniquely identify the individual
Indirect Identifiers: Information that can be combined with other information to potentially identify a specific individual.- Place of medical treatment or doctor's name
- Gender
- Rare disease or treatment
- Sensitive data like illicit drug use or other "risky behaviors"
- Place of birth
- Socioeconomic data, like workplace, occupation, annual income, education, etc.
- General geographic indicators, like postal code of residence
- Household and family composition
- Ethnicity
- Birth year or age
- Verbatim responses or transcripts
- Anonymization Used as a more broad term to encompass two types of tasks to reduce disclosure risk for identifiers
Masking
Alter direct identifiers so that the original is no longer useable for analysis.
Deleteitems like social security numbers and replaceidentifiers with pseudonyms or randomized codes.
De-identification
Minimal distortion of data so that they retain utility for analysis, while adequately protecting privacy.
Methods include generalizing data elements, such as replacing age with range values; or more advanced statistical techniques, such as suppression of outlier values, grouped averaging or record swapping.
(Video) A Day In The Life Of A Clinical Data Manager - HIPAA's Privacy Rule Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to protect individuals’ medical records and other personal health information
Limited Data Sets (LDS) --§164.514(e)
Remove or anonymize HIPPAdirect identifiers, and "facial" identifiers.
Certain dates, geographic location to zip code level, and birth dates may remain.
Indirect identifiers may also remain if not easily removed.
"Safe Harbor" Anonymization Level --§164.514(b)
18 direct identifiers, 3-digit zipcode truncation, and year only dates.
Alter indirect identifiers to sufficiently limit "actual knowledge" of data that could, alone or in combination with other information, re-identify a data subject.
"Expert determination" Statistically De-identified Datasets --§164.514(b)(1)
Removeor maskall direct and indirect identifiers.
Statistical techniques can beapplied to make remaining risk "very small"
A trained statistical professional should be consultedto adequately assist in preparing datasets in order toassessand mitigatedisclosure risk.
Clinical Data Collection
Before Collection:
Prepare an anonymization scheme and/or secure key code list.
Keep participantcontact info secure and separate from materials you bring to the field.
Document identifiers and their substitutions in a secure list or codebook.
Note which variablescontain indirect identifiers to check when de-identifying the data.
During Collection:
Use passwords/encryption for mobile devices.
Use pseudonyms/codes.
Collect only the identifiers necessary for the research.
After Collection:
Sensitive data that contain potentially identifying information will likely need to be modified prior to sharing with the public.
Consider retaining multiple versions of the data.
The level of de-identification depends on the plans for accessing and sharing data.
Options for accessing and sharing data are based on the method of de-identification applied.
Public Access: Statistically de-identified datasets are generally approved for public release and deposit to open access data repositories.
Restricted Access: For data applying only Limited Data Sets and Safe Harbor levels. This means sharing data only with approved collaborators or investigators under a Data Use Agreement.
The following chart summarizes your choices:
Secure Data Storage
When working with clinical or sensitive data it is the responsibility of everyone who can access the data to keep files within secure storage at all times. Use networked storage managed by Harvard whenever feasible, particularly for collaborative access to files. Similar levels of security are a best practice for any data from human subjects or other restricted access.
Review the Harvard Security Levels for Research Data
- REDCap Secure web application for data capture for research studies
REDCap is a free, secure, web-based application designed to support data capture for research studies. The system was developed by a multi-institutional consortium initiated at Vanderbilt University. Data collection is customized for each study or clinical trial by the research team with guidance from Harvard Catalyst EDC Support Staff. REDCap is designed to comply with HIPAA regulations.
REDCap is a mature, secure web application for building and managing online surveys and databases:
Design your own survey electronically
Share data securely with research staff and external collaborators
Built in tools for viewing EPIC data, and limited de-identification
Available Harvard Licenses:
Harvard Medical School (HMS REDCap is NOT a HIPAA compliant service)
Harvard School of Public Health
Additional Harvard Affiliated Institutions
Additional Resources
- Clinical Research Datasets
Clinical research data may be available through national or discipline-specific organizations.Level of access is likely restricted but available through proper channels. Proprietary research data may also be available through individual use agreements.
Biologic Specimen and Data Repository Information Coordinating Center (NHLBI)
Listing of studies with resources available for searching and request via BioLINCC.
Biomedical Translational Research Information System (BTRIS)
Research data available to the NIH intramural community only.
Clinical trials data. Partners include Pharmaceutical companies.
Limited Access Datasets.
Harvard Health Care Policy (HCP) - Center for Healthcare Data Analytics (CHDA)
Medicare and Medicaidhealth care data for research purposes. Restricted to collaborations with HCP faculty. Details on current data available through theHCP Hub CHDA on the Harvard Intranet.
Harvard Medical School Department of Biomedical Informatics (DBMI) Data Portal
Growing catalog of DBMI resources, including datasets.
- Additional Readings
Is there such thing as being truly anonymous?
Harvard Professor Re-Identifies Anonymous Volunteers in DNA Study (Tanner, 2013)
Only You, Your Doctor, and Many Others May Know(Latanya Sweeney, 2015)
Re-identification of Patients in Maine and Vermont Statewide Hospital Data (Ji Su Yoo et al. 2018)
Genome Hackers Show No One’s Data is Anonymous Anymore (Megan Molteni, 2018)
- (Video) Clinical Data Management
FAQs
What is meant by clinical data management? ›
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing.
What are the steps involved in clinical data management? ›Clinical Data Management (CDM) is a critical phase in clinical research which results in collection of reliable, high-quality and statistically sound data. It consists of three phases i.e. start up, conduct and close out.
Is Clinical Data Manager a good career? ›Skilled clinical data managers are in great demand; however, when looking for positions, find roles that relate to your individual skills and past experiences. Additionally, it is key to understand the professional requirements for clinical data managers to focus your career and address undeveloped skills.
What is CDM programming? ›The CDM Program delivers cybersecurity tools, integration services, and dashboards that help participating agencies improve their security posture by: Reducing agency threat surface. Increasing visibility into the federal cybersecurity posture. Improving federal cybersecurity response capabilities.
What is the job of a CDM team? ›The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the data manager ensures that data is collected, validated, complete, and consistent.
What are the duties of clinical data management? ›Clinical data managers collect data from medical research projects, analyze it for trends, and ensure that it's kept secure and reported accurately. Corporate research and development also employs many statisticians.
What are the 3 main processes of data management? ›MDM helps ensure businesses don't use multiple, potentially inconsistent versions of data in different parts of business, including processes, operations, and analytics and reporting. The three key pillars to effective MDM include: data consolidation, data governance, and data quality management.
Who qualifies for clinical data management? ›In general, you can become a Clinical Data Manager after completing your 4 year Bachelor's Degree in a related discipline. Depending on the type of Clinical Data Manager role you're pursuing, you may want to explore certification in certified coding specialist.
What is the salary of Clinical Data Manager role? ›Clinical Data Manager salary in India ranges between ₹ 2.4 Lakhs to ₹ 9.5 Lakhs with an average annual salary of ₹ 5.4 Lakhs.
Is data management a stressful job? ›Every job is stressful and tiring, but those who work with data are often especially vulnerable to burnout. Data workers, along with engineers in other fields, tend to have more analytical personalities and can be more sensitive to stress at work.
What is the salary of a Clinical Data Manager in the United States? ›
The average Clinical Data Manager salary in the United States is $117,721 as of January 26, 2023, but the range typically falls between $107,362 and $130,261.
Which software is used for clinical data management? ›Best Clinical Data Management Systems include:
Merative Clinical Development, Bioclinica ICL, and Oracle Clinical One.
Clinical data management (CDM) covers all the aspects of processing clinical data and includes determining the accuracy, security and reliability of the data for analyses. The process of CDM includes several activities, like data management plan development, data collection and data processing.
What does CDM mean in healthcare? ›What Is The Hospital Chargemaster? The chargemaster, or charge description master (CDM), is a database that contains a comprehensive listing of items that could produce a charge. The chargemaster will have a record for everything in the health system that relates to patient care.
What are the 5 main parts of CDM? ›- The application of CDM 2015 and definitions.
- The duties of construction project clients.
- The duties of other duty holders including designers, principal designers, contractors and principal contractors.
- General requirements for all construction sites.
Mid-Study Changes
Clinical Data Management is a complicated process. It has several stakeholders, from researchers to CROs and sponsors. This makes CDM difficult, especially with regard to mid-study modifications (MSCs). Mid-study modifications are changes in protocols and study Management Plans (SDMPs).
- medical coding.
- certified medical coder.
- clinical research.
- clinical data management.
- pharmacovigilance.
- cdm.
- coding.
- medical.
“The clinical data manager must understand good clinical practices (GCP), protocol, protocol deviations, metadata, basic SDTM mapping, programming and Excel.” As clinical data managers work in tandem with project managers, they are stepping into a larger role within a CRO.
What is an example of data management? ›Using a data management platform provides you with control over your data for multiple use cases. For example, a data management platform could collect customer data from multiple sources, then analyze and organize it to segment your customers by purchase history.
What are the methods of data management? ›- Build strong file naming and cataloging conventions. ...
- Carefully consider metadata for data sets. ...
- Data Storage. ...
- Documentation. ...
- Commitment to data culture. ...
- Data quality trust in security and privacy. ...
- Invest in quality data-management software.
What are the 4 essential data types? ›
Most programming languages support various types of data, including integer, real, character or string, and Boolean.
What is the first step in data management? ›Data collection
Collecting data is the first step in data processing. Data is pulled from available sources, including data lakes and data warehouses. It is important that the data sources available are trustworthy and well-built so the data collected (and later used as information) is of the highest possible quality.
It is usually performed in a step-by-step process by a team of data scientists and data engineers in an organization. The raw data is collected, filtered, sorted, processed, analyzed, stored, and then presented in a readable format.
What are the 7 stages of data analysis? ›- Defining the question.
- Collecting the data.
- Cleaning the data.
- Analyzing the data.
- Sharing your results.
- Embracing failure.
- Summary.
Average salary for a Clinical Data Manager in Bengaluru/Bangalore is ₹5.6 Lakhs per year (₹46.7k per month).
How long is clinical data management course? ›FAQs About Clinical Data Management Training
The course duration is 6 months In- class sessions = 6 months & Internship = 2 months(Optional).
When applying for clinical data manager jobs, you may find that most positions require at least a bachelor's degree. However, many individuals in this role have a graduate education in computer science, engineering or information technology.
What is the highest paid Clinical Data Manager? ›The salaries of Clinical Data Managers in the US range from $19,539 to $514,199 , with a median salary of $100,775 . The middle 57% of Clinical Data Managers makes between $100,775 and $238,400, with the top 86% making $514,199.
What is the highest paying job in data? ›- Data Scientist Salary. Data Scientists earn an average salary range of $98,000-$256,000. ...
- Data Architect Salary. Data Architects earn an average salary range of $168,000-$260,000. ...
- Big Data Engineer Salary. ...
- BI Architect Salary. ...
- Data Warehouse Engineer Salary. ...
- Data Engineer Salary.
Data management is paid well and has good job security. There is a myriad of industries and types of data management. If you possess a knack for technology, software, and organization, a career in database management may be a great option.
Why is data management so hard? ›
Managing data can be difficult because there are many different ways in which data can come into existence. Data can come from different sources like social media, IoT devices, sensors, databases, and more.
Do data jobs pay well? ›Do Data Analysts Make Good Money? Yes, data analysts do make a lot of money. According to the Bureau of Labor Statistics (BLS), the average salary across all occupations in the US is $58,260. The average salary of a data analyst is well above that.
Do you need a degree to be a data manager? ›A bachelor's degree is the basic entry-level requirement for a data manager. Degrees in computer science, computer engineering, statistics or business administration can be useful for this field. You may need a master's degree for senior data manager positions.
How much does a Clinical Data Manager at Pfizer make? ›$131,610. The estimated total pay for a Clinical Data Manager at Pfizer is $131,610 per year.
How much do DMS make a year? ›| Industry | Employment (1) | Annual mean wage (2) |
|---|---|---|
| General Medical and Surgical Hospitals | 46,200 | $ 80,200 |
| Offices of Physicians | 18,710 | $ 80,030 |
| Medical and Diagnostic Laboratories | 8,310 | $ 74,190 |
| Outpatient Care Centers | 2,860 | $ 109,670 |
To diagnose and treat individual patients effectively, individual care providers and care teams must have access to at least three major types of clinical information—the patient's health record, the rapidly changing medical-evidence base, and provider orders guiding the process of patient care.
What are examples of clinical data? ›At present, clinical profiles include data on demographics, diagnoses, disease comorbidities, symptoms, medications, procedures, and laboratory measures.
What are the CDM interview questions? ›- Can you describe the three data management stages? ...
- What is the importance of leveraging existing systems to manage clinical data? ...
- What are some causes of inaccurate reporting? ...
- What are some solutions for reducing inaccurate reporting?
The term has to do with whether or not you treat patients or provide direct patient care of any type, in which case your job is clinical. Non-clinical work may support patient care, but the work does not provide direct diagnosis, treatment, or care for the patient.
Who are the key members involved in data management? ›...
In general, the roster looks like this:
- Project Supervisor;
- Project Clinical Data Manager;
- Data Management Assistant;
- Database Designer;
- Database Administrator;
- Medical Coding Associate;
- Quality Assurance Associate;
- Data Entry Manager;
What is the first step in clinical data management? ›
The first step in CDM is the review and the finalization of the documents of the study, which gives an idea about how to design a database which will be later used for data collection.
What are the most important aspects of clinical data management? ›Quality in clinical data management. One can maintain the quality of clinical trial data through inspection, evaluation, and standardization by using various tools and processes. The two crucial steps to manage data quality are quality assurance and quality control, known usually as QA and QC.
What is the salary of clinical data management jobs? ›Clinical Data Manager salary in India ranges between ₹ 2.4 Lakhs to ₹ 9.5 Lakhs with an average annual salary of ₹ 5.4 Lakhs. Salary estimates are based on 629 latest salaries received from Clinical Data Managers.
How do you collect clinical data? ›Different data collection approaches which are commonly used in the conduct of clinical research include questionnaire surveys, patient self-reported data, proxy/informant information, hospital and ambulatory medical records, as well as the collection and analysis of biologic samples.
What qualifies as clinical data? ›Clinical data is a collection of data related to patient diagnosis, demographics, exposures, laboratory tests, and family relationships.