Comparison of Paper Patient Records Vs RedCap for Data Collection
Sidra Ashfaque
CRP104: Clinical Study Administration
Patricia DiCiano
March 27, 2023
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The method of collecting data is an essential component when establishing source
documents and Case Report Forms (CRF) as it should follow good documentation practices and
the principles of ALCOA-C. Paper Patient Records are documents record various types of data
and comprise of several documents such as: progress notes, adverse event logs, concomitant
medications log, adverse events log, assessments checklist, contact information (emergency
contact information), medical history etc. (Paper Patient Records, 2023). Paper Patient Records is
considered an older way of recording patient data and innovations such as REDCap have been
developed to record patient data in source documents and CRF’s. REDCap is referred to as a webbased application which is developed by Vanderbilt University to obtain data for clinical research
and generate projects and databases (Patridge & Bardyn, 2018). It is a quite comprehensive and
flexible tool which can operate on the following multiple operating systems such as UNIX,
Windows, and Mac, and Linux (Patridge & Bardyn, 2018). REDCap is compliant with HIPAA
and is considered very secure and instinctive (Patridge & Bardyn, 2018). It is designed in a way to
provide steady environment so that the research teams can gather and store very sensitive and
confidential information (Patridge & Bardyn, 2018). In my opinion REDCap is an efficient method
of collecting data compared to paper patient records as REDCap since it is more secure and closely
ties in with the principles of GDP and ALCOA-C (contemporaneous and legible).
ALCOA-C outlines attributes for good documentation practices developed by US-FDA
(Bargaje, 2011). The following attributes of ALCOA-C are attributable, legible, contemporaneous,
complete, original, and accurate. One of the key attributes of ALCOA-C which REDCap meet is
contemporaneous. Contemporaneous is defined as an attribute according to which the information
should be recorded in an appropriate time frame through the flow of events, and if a clinical
observation cannot be executed the chronology should be documented (Bargaje, 2011).
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Additionally appropriate length of delay should be stated and justified (Bargaje, 2011). The data
being recorded in REDCap follows tabular format and the display included timestamps and
illustrates which survey questions are being answered (Patridge & Bardyn, 2018). The timestamp
which is being generated allows the user to build a report which can be generated at regular
intervals (Patridge & Bardyn, 2018). This could be especially helpful in collecting data in source
documents as the sequence of events should be documented (Di Ciano, 2023). REDCap also
possess the ability to formulate a calendar to schedule and track major critical study events such
as: participants visit, blood draws etc. (REDCap, 2023). The feature could be extremely beneficial
in collecting data in case report forms since data on blood draws is recorded on case report forms
(Di Ciano, 2023). These two features are not present when utilizing paper patient method to record
the data. The two attributes could add to the flexibility and ease when collecting data and most
importantly could save time as compared to using paper patient method since these details have to
be added manually when utilizing paper patient method of data collection.
Another key attribute of the ALCOA-C which REDCap meets the criteria for is legible
meaning that readable and the signatures are identifiable. An individual can generate surveys and
could utilize the following features: electronic signatures, forming matrix questions, and
developing questions by utilizing stop actions and branching logic (Patridge & Bardyn, 2018).
Paper patient records also use signatures to identify if the source documents or CRF’s are legible
or not however does not include details such as: forming matrix questions and developing
questions by utilizing stop actions and branching log. The use and importance of signatures is also
mentioned in the code of federal regulations stating the following, “all data entries shall be dated
on the date of entry and signed or initialed by the person entering the data” (Di Ciano, 2023).
Overall, the inclusion of signatures and other features in REDCap makes it compliant with one of
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the ALCOA-C principles as well as with one of the GDP conventions and makes it a more
convenient method compared to paper patient records.
One of the advantages of REDCap is it is secure, web-based, and most importantly this
software carries the propensity for the data to be entered from any part of the world with the use
of secure web authentication, Secure Sockets Layer (SSL) encryption, and data logging and allows
multisite access (RedCap, 2023). It is known to be more secure than Microsoft Excel and Microsoft
Word and could be accessed from any device with a web browser and Internet connection (Bargaje,
2011). The essential features such as daily backups, basic support, and audit trail makes REDCap
extensively secure (Bargaje, 2011). These key features make REDCap compliant with one of the
GDP from code of federal regulations with respect to protection of records and procedures of
keeping the electronic records. The code of federal regulations requires the system to be able to
physically and logically support record retrieval throughout the period of retention and there
should be procedures mentioned how the system access is granter or being revoked (Di Ciano,
2023). One disadvantage of Paper patient records is the records are not secure enough and the
access to the records is being guarded through doors, locks, identification cards and long sign-out
procedures for the authorized personnel and most of the unauthorized access to the records of the
patients stimulate no alerts and it was also not known, “what” records have been viewed (Harman
& Cathy, 2012). Additionally, the paper patient records are only accessible to one user which
makes its accessibility quite limited (Harman & Cathy, 2012). All in all, key features of REDCap
make it a way more secure method of collecting data compared to paper patient records and those
key features makes it more compliant with good documentation procedures.
Furthermore, audit trails are another feature of REDCap which extensively adds on to the
security and surveillance of collecting data. Audit trails tracks the activity of the system by
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initiating date and time stamp for the entries, comprehensive listings of the data being viewed (how
length of the time it was viewed by and by whom) and the logs of modifications being to the data
(Harman et al., 2012). The administrators also possess the ability to provide information of “what”
reports were being printed, the quantity of the screenshots being taken, the exact location as well
as the computer which were being utilized to submit a request (Harman et al., 2012). Alerts are
also being utilized to flag a suspicious or an unusual activity. For example, examining information
on patient (attempting to access information) an individual is not authorized to view (Harman et
al., 2012). The administrators could extract reports on these users to evaluate their activity
(Harman et al., 2012). One of the advantages of REDCap is it automatically audit trails all the
activity and is now becoming a standard requirement for mainly all the studies (Hackman &
Scarpella, 2019). One of the requirements of good documentation practices for electronic records
is, “when records are created, modified, maintained, or transmitted electronically, we must employ
procedures and controls designed to ensure the authenticity, integrity, and when appropriate, the
confidentiality of electronic record” (Di Ciano, 2023). RedCap is compliant with GDP, specifically
with this requirement since the inclusion of audit trails serves to fulfill this requirement. Also, code
of federal regulations also mentions the use of audit trials specifying these are systems to, “systems
to identify the identity of users creating, modifying or transmitting data” (Di Ciano, 2023). There
is no such concept of audit trails in paper patient records however, “all data entries shall be dated
on the date of entry and signed or initialed by the person entering the data” (Di Ciano, 2023).
Additionally, there is no such practice in place in paper patient records to know that who viewed
the data, information about the individual who viewed the data, when was it viewed, logs of
modifications to the data etc. Overall, these are the key inconsistencies in paper patient records
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which have the propensity to raise questions in terms on how secure this method is for data
collection.
Validation is one of the important key concepts when collecting data electronically
according to the code of federal regulations and emphasizes on the idea that the testing system
should do based on what they are expected to do, and the documents should be at one’s disposal
for review and audit (Di Ciano, 2023). Validation also corroborates that correct data is being
entered into the system and the value is within the walls of expected range (Scarpella & Hackman,
2019). Some of the built-in validations in REDCap are the following: date, time, integer, number,
zip code, phone, and email. And numeric and date fields have a minimum and maximum value
being set up (Scarpella & Hackman, 2019). According to the good documentation practices all
dates should be written in a defined manner (dd/mm/yyyy) (Di Ciano, 2023). Moreover, there
should be no overwrites and any written error should be crossed out in a way that the original
information is still legible (Di Ciano, 2023). The entries should not be scribbled out or “whiteout”,
which would maintain the integrity of the document (Di Ciano, 2023). According to GDP from
code of federal regulations, “all data entries shall be dated on the date of entry and signed or
initialed by the person entering the data” (Di Ciano, 2023). REDCap has real time data validation
which allows accurate entrance of date according to the format of GDP (Scarpella & Hackman,
2019). The numeric and date fields have minimum and maximum value being set up which would
not allow inaccuracy when mentioning dates (Scarpella & Hackman, 2019). For example, the
system would not allow the dates being mentioned like: (dd/yyyy/mm). However, when it comes
to paper patient records these features are not present and there are greater chances of entering
dates in an inaccurate format or missing dates. One of the examples was adverse events log of an
institution named, “Family Hospital” (Di Ciano, 2023). The dates were mentioned as, “2-20 or 12-
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4”. Moreover, the log was not signed as well which violated GDP from code of federal regulations.
The built-in validations in REDCap could be significantly helpful in collecting data on source
documents (reporting adverse events and SAE’s etc.) and case report forms (study visits, physical
exam results etc.) since they both require dates to be mentioned in an accurate format and could
significantly contribute to the quality and consistency of the documents. Overall, the built-in
validation in REDCap allows a more comprehensive approach of collecting data when it comes to
the accuracy, quality, and consistency of data compared to the paper patient record which is
susceptible to inaccuracies and could lead various other issues in record keeping.
Paper patient records being a classical method is used to report events, such as the course
of an illness, and as a tool for communication among clinicians and could be used for data
collection in the form of source documents and case report forms and REDCap, an advanced webbased tool to capture data for research studies. Both methods have their own advantages and
disadvantages however REDCap is a methodical, efficient and secure method of collecting data as
compared to paper patient record after critically analyzing both methods with a strong focus on
which method is more compliant with GDP and ALCOA-C principles. To conclude, REDCap data
collection method is better than paper patient records since it is more secure (audit trials, basic
support, Secure Sockets Layer (SSL) encryption, and data logging), validating, allows multisite
access, strongly meet the ALCOA-C principles (legible and contemporaneous) as well as good
documentation practices.
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References
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