Guidance for Industry 

 
Electronic Source Data in 

Clinical Investigations 

 
  
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 

Center for Devices and Radiological Health (CDRH) 

  
 
September 2013 

Procedural
 
     
Guidance for Industry 

 
Electronic Source Data in 

Clinical Investigations 

 
Additional copies are available from: 

Office of Communications, Division  of Drug Information 
 
Center for Drug Evaluation  and Research 
 
Food and  Drug Administration
  
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Silver Spring, MD 20993-0002 
 
Tel:   301-796-3400; Fax:  301-847-8714; Email:  druginfo@fda.hhs.gov  

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 

and/or 
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Email:   ocod@fda.hhs.gov 

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and/or 
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Email: dsmica@cdrh.fda.gov; Fax: 301.847.8149
 
 (Tel) Manufacturers Assistance:  800.638.2041 or 301.796.7100 
 
  
 
  
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 

Center for Devices and Radiological Health (CDRH) 

  
September 2013 

Procedural 

      
 
Guidance for Industry 

 
Electronic Source Data in 

Clinical Investigations 

 
 
 
 
 
 
 
 
For questions regarding this guidance please contact: 
 
CDER: 	Jonathan.Helfgott@fda.hhs.gov / 301-796-5636 or 
            Ronald.Fitzmartin@fda.hhs.gov / 301-796-5333 
 
CBER: 	Bhanu.Kannan@fda.hhs.gov  / 301-827-6188 
 
CDRH: 	Irfan.Khan@fda.hhs.gov  / 301-796-5659 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiological Health (CDRH) 
  
September 2013 

Procedural 

 
      
 
 
TABLE OF CONTENTS 

 
I.   INTRODUCTION............................................................................................................. 1
  
II.   BACKGROUND ............................................................................................................... 2 
 
III.   ELECTRONIC SOURCE DATA.................................................................................... 3 
 
A.   Data Capture .................................................................................................................................. 3
  
1.  Electronic Source Data Origination ................................................................................................. 3
  
2.  Source Data Capture ........................................................................................................................ 4
  
3.  Data Element Identifiers .................................................................................................................. 5
  
4.  Modifications and Corrections......................................................................................................... 6
  
5.  Use of Electronic Prompts, Flags, and Data Quality Checks in the eCRF ...................................... 6 
 
B.   Data Review.................................................................................................................................... 6
  
1.  Clinical investigator(s)..................................................................................................................... 6
  
2.  Modifications and Corrections During Clinical Investigator(s) Review of the eCRF ..................... 7
  
C.   Retention of Records by Clinical Investigator(s) ........................................................................ 7
  
D.   Data Access..................................................................................................................................... 8
  
IV.  	 USE AND DESCRIPTION OF COMPUTERIZED SYSTEMS IN CLINICAL 

INVESTIGATIONS.......................................................................................................... 8 
 
REFERENCES.............................................................................................................................. 9 
 
GLOSSARY OF TERMS........................................................................................................... 10 
 
 
 
      
1
 
Guidance for Industry  
Electronic Source Data in Clinical Investigations 

 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any  person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
I.  INTRODUCTION 
 
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), 
clinical investigators, and others involved in the capture, review, and retention of electronic 
source data in FDA-regulated clinical investigations.2  In an effort to streamline and modernize 
clinical investigations this guidance promotes capturing source data in electronic form, and it is 
intended to assist in ensuring the reliability, quality, integrity, and traceability of data from  
electronic source to electronic regulatory submission.  
 
This guidance addresses source data in clinical investigations used to fill the predefined fields in 
an electronic case report form (eCRF), according to the protocol.  The guidance discusses the 
following topics related to electronic source data: 
  
   Identification and specification of authorized source data originators 
   Creation of data element identifiers to facilitate examination of the audit trail by 
sponsors, FDA, and other authorized parties  
   Ways to capture source data into the eCRF using either manual or electronic methods  
   Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic 
data 
   Use and description of computerized systems in clinical investigations 
 
This guidance is intended to be used together with the FDA guidance for industry on 
Computerized Systems Used in Clinical Investigations (the computerized systems guidance),3   
                                                 
1 This  guidance has been  prepared by the Center for Biologics Evaluation and Research, the Center for Drug  
Evaluation and Research, and the Center for  Devices and Radiological  Health at the Food and Drug Administration. 
2 See definitions in  21 CFR 50.3 and  312.3.  
3  We  update  guidances periodically.  To make sure you  have the most recent version of a guidance, check the FDA  
Drugs guidance Web page  at  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; the Vaccines, 
Blood, and Biologics guidance Web page  at  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm; or the Medical  
Devices guidance Web page  at  
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.   
    
  1 

    
and FDA regulation on Electronic Records and Electronic Signatures.4 Electronic structures and 
standards related to electronic submissions are out of scope for this guidance. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
II.  BACKGROUND 
 
With the use of computerized systems for capturing clinical investigation data, it is common to 
find at least some source data recorded electronically.  Common examples include, but are not 
limited to clinical data initially recorded in electronic health records maintained by healthcare 
providers and institutions, electronic laboratory reports, digital medical images from devices, and 
electronic diaries completed by study subjects. 
 
FDA regulations define an electronic record as any combination of text, graphics, data, audio, 
pictorial, or other information represented in digital form that is created, modified, maintained, 
archived, retrieved, or distributed by a computer system.5  An eCRF is an example of an  
electronic record. 
 
The eCRF is an auditable electronic record of information that generally is reported to the 
sponsor on each trial subject, according to a clinical investigation protocol.  The eCRF enables 
clinical investigation data to be systematically captured, reviewed, managed, stored, analyzed, 
and reported. 
 
Source data includes all information in original records and certified copies of original records of 
clinical findings, observations, or other activities in a clinical investigation used for 
reconstructing and evaluating the investigation.6  Access to source data is critical to the review  
and inspections of clinical investigations.  The review of source data by both the FDA and 
sponsor is important to ensure adequate protection of the rights, welfare, and safety of human 
subjects and the quality and integrity of the clinical investigation data. Source data should be 
attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the 
regulatory requirements for recordkeeping.7  Capturing source data electronically and 
transmitting it to the eCRF should:  
 
                                                 
4 See 21 CFR part 11. 
5 21 CFR 11.3(b)(6). 
6 In  21 CFR  312.62(b), reference is made to  records that are part of case histories as supporting data; the ICH 
guidance for industry  E6 Good  Clinical Practice: Consolidated Guidance  (the ICH E6 guidance) (available at  
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm) uses the term  
source data/documents.  For the purpose of this guidance, these terms describe the same information and have  
been used interchangeably. 
7 For the principal record  keeping requirements for clinical  investigators and sponsors developing  drugs and 
biologics, see 21 CFR  312.50, 312.58,  312.62, and 312.68. For medical devices, see 21 CFR 812.140 and 812.145.  
  2 

    
 	  Eliminate unnecessary duplication of data  
 	  Reduce the possibility for transcription errors   
 	  Encourage entering source data during a subjects visit, where appropriate  
 	  Eliminate transcription of source data prior to entry into an eCRF 
 	  Facilitate remote monitoring of data 
 	  Promote real-time access for data review 
 	  Facilitate the collection of  accurate and complete data   
  
III.   ELECTRONIC SOURCE DATA  
 
Electronic source data are data initially recorded in electronic format.  They can include 
information in original records and certified copies of original records of clinical findings, 
observations, or other activities captured prior to or during a clinical investigation used for 
reconstructing and evaluating the investigation.    
 
 
A.  Data Capture 
 
1.   Electronic Source Data Origination  
 
A data element in an eCRF represents the smallest unit of observation captured for a subject in a 
clinical investigation. Examples of data elements include race, white blood cell count, pain 
severity measurement, or other clinical observations made and documented during a study.  Each 
data element is associated with an authorized data originator.  Examples of data originators 
include, but are not limited to: 
 
 	  Clinical investigator(s) and delegated clinical study staff    
  
 	  Clinical investigation subjects or their legally authorized representatives  
 
 	  Consulting services (e.g., a radiologist reporting on a computed tomography (CT) scan) 
 
 	  Medical devices (e.g., electrocardiograph (ECG) machine and other medical instruments 
such as a blood pressure machine) 
 
 	  Electronic health records (EHRs) 
  
 	  Automated laboratory reporting systems (e.g., from central laboratories) 
 
 	  Other technology 
 
A list of all authorized data originators (i.e., persons, systems, devices, and instruments) should 
be developed and maintained by the sponsor and made available at each clinical site.  In the case 
of electronic, patient-reported outcome measures, the subject (e.g., unique subject identifier) 
should be listed as the originator. 
 
When identification of data originators relies on identification (log-on) codes and unique 
passwords, controls must be employed to ensure the security and integrity of the authorized user  
  3 

    
names and passwords.8  When electronic thumbprints or other biometric identifiers are used in 
place of an electronic log-on/password, controls should be designed to ensure that they cannot be 
used by anyone other than their original owner.   
 
When a system, device, or instrument automatically populates a data element field in the eCRF, a 
data element identifier (see section III.A.3) should be created that automatically identifies the 
particular system, device, or instrument (e.g., name and type) as the originator of the data 
element.  For example, if an ECG machine automatically transmits to the eCRF, a data element 
identifier should be generated that identifies the ECG machine as the originator.  
 
2. 	 Source Data Capture   
 
Data can be entered into the eCRF either manually or electronically as described below. 
 
a. 	  Direct Entry of Data Into the eCRF 
 
Many data elements (e.g., blood pressure, weight, temperature, pill count, resolution of a 
symptom or sign) in a clinical investigation can be obtained at a study visit and can be entered 
directly into the eCRF by an authorized data originator.  This direct entry of data can eliminate 
errors by not using a paper transcription step before entry into the eCRF.   For these data 
elements, the eCRF is the source.  If a paper transcription step is used, then the paper 
documentation should be retained and made available for FDA inspection (see section III.A.2.c). 
 
When pertinent supportive information is available, FDA could request other documents during 
an inspection to corroborate a direct entry of source data elements into the eCRF by an 
authorized data originator.  For example, at an initial visit, a clinical investigator might ask a 
subject about underlying illnesses, and proceed to  enter the illness(es) in an eCRF.  During an 
FDA inspection, a record may be requested for evidence of testing or the use of medications to 
corroborate a diagnosis. 
 
Typically, images (e.g., CT scans) are not included as data elements in an eCRF, but rather the 
clinical interpretation of the image is included as a predefined data field.  When an image (e.g., a 
CT scan) is sent to a central reading center for clinical interpretation and the radiologist is 
authorized to enter data directly into the eCRF, then  the radiologists assessment (e.g., normal) 
is the data element as predefined in the eCRF, the radiologist is the data originator and the CT 
scan is the pertinent clinical record.  However, when the radiologist sends a report to a clinical  
investigator(s) who transcribes the data into the eCRF, the clinical investigator(s) is the 
originator and the source is the radiologists report. 
 
b. 	 Automatic Transmission of Data From Devices or Instruments Directly to 
the eCRF 
 
When a device or instrument is the data originator (e.g., blood pressure monitoring device or 
glucometer) and data are automatically transmitted directly to the eCRF,  the eCRF is the source. 
If a process is used by which the device or instrument transmits data automatically to, for 
                                                 
821 CFR 11.300(a); see also the computerized systems guidance. 
  4 

    
example, an electronic health record system or to a service providers database, then the EHR or 
the service providers database is the source. 
 
c. 	 Transcription of Data From Paper or Electronic Sources to the eCRF 
  
Data elements can be transcribed into the eCRF from paper or electronic source documents.  The 
authorized person transcribing the data from the source documents is regarded as the data 
originator. For these data elements, the electronic or paper documents from which the data 
elements are transcribed are the source.  These data must be maintained by the clinical 
investigator(s) and available to an FDA inspector if requested (e.g., an original or certified copy 
of a laboratory report, instrument printout, progress notes of the physician, the study subjects 
hospital chart(s), nurses notes).9  
 
d. 	 Direct Transmission of Data From  the Electronic Health Record to the 
eCRF 
 
Data elements originating in an EHR can be transmitted directly into the eCRF automatically. 
Unlike a direct transmission to an eCRF from instruments or medical devices, EHRs can use 
intervening processes (e.g., algorithms for the selection of the appropriate data elements).  For 
this reason the EHR is the source, and the pertinent data for the subjects in the clinical study 
should be made available for review during an FDA inspection. 
 
The ability of sponsors and/or monitors to access health records of study subjects in clinical 
information systems relevant to the clinical investigation should not differ from their ability to 
access health records recorded on paper.  
 
e. 	 Transmission of Data From Patient-Reported Outcome (PRO) Instruments 
to the eCRF 
 
When a PRO instrument is used by a subject to transmit data elements directly to the eCRF, the 
subject is the data originator and the eCRF is the source.   If a process is used by which the 
subject uses the instrument to transmit data to a technology service provider database, the service 
provider database is the source. 
 
3.	   Data Element Identifiers  
 
The eCRF should include the capability to record who entered or generated the data and when it 
was entered or generated. Changes to the data must not obscure the original entry, and must 
record who made the change, when, and why.10  Data element identifiers should be attached to 
each data element as it is entered or transmitted by the originator into the eCRF.  Data element 
identifiers should contain the following: 
 
 	  Originators of the data element (including those data elements entered manually (e.g., by 
the clinical investigator(s)) and automatically (e.g., EHR, device, or instrument)) 
                                                 
9 21 CFR 312.62(b) and  812.140(a)(3). 
10 21 CFR 11.10(e). 
  5 

    
   Date and time the data element was entered into the eCRF (the audit trail begins at the 
time the data are transmitted to the eCRF)   
   Clinical investigation subjects to which the data element belongs 
  
These data element identifiers will allow sponsors, FDA, and other authorized parties to examine 
the audit trail of the eCRF data (and this audit trail should be readily available in a human 
readable form).   In addition, they provide information that will allow FDA to reconstruct and 
evaluate the clinical investigation.   
 
Although it is not necessary to automatically display the data element identifiers wherever data 
elements appear in the eCRF, the eCRF system  should include a functionality that enables FDA 
to reveal or access the identifiers related to each data element.  
 
4.  Modifications and Corrections 
 
Only a clinical investigator(s) or delegated clinical study staff should perform modifications or 
corrections to eCRF data. Modified and/or corrected data elements must have data element 
identifiers that reflect the date, time, originator and reason for the change, and must not obscure 
previous entries.11  A field should be provided allowing originators to describe the reason for the 
change (e.g., transcription error).  Automatic transmissions should have traceability and controls 
via the audit trail to reflect the reason for the change.   
 
5.  Use of Electronic Prompts, Flags, and Data Quality Checks in the eCRF  
 
We encourage the use of electronic prompts, flags, and data quality checks in the eCRF to 
minimize errors and omissions during data entry.12  Prompts can be designed to alert the data 
originator to missing data, inconsistencies, inadmissible values (e.g., date out of range), and to 
request additional data where appropriate (e.g., by prompting a clinical investigator(s) to 
complete an adverse event report form triggered by a critical laboratory result).  Clinical 
investigator(s) should have the ability to enter comments about issues associated with the data.  
Sponsors should describe (e.g., in a data management plan) the electronic prompts, flags, and 
data quality checks that are designed to address, for example, data inconsistencies, missing data, 
and entries out of range. 
 
B.  Data Review  
 
1.  Clinical investigator(s)  
 
The clinical investigator is the individual who conducts a clinical investigation (i.e., under whose 
immediate direction the test article or investigational product is administered or dispensed to, or 
used involving, a subject), or in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.13  
 
   
                                                 
11 21 CFR 11.10(e). 

12 See the computerized systems guidance. 

13 See definitions in  21 CFR 312.3(b) and  812.3(i). 

  6 

    
a.  Clinical  Investigator(s) Review and Electronic Signature 
 
To comply with the requirement to maintain accurate case histories14 clinical investigator(s) 
should review and electronically sign the completed eCRF for each subject before the data are 
archived or submitted to FDA.15  Use of electronic signatures must comply with part 11 (21 CFR 
part 11). 
      
b.	   Data Exempt From Investigator Review 
 
Under certain circumstances, the clinical investigator(s) can be masked to specific data in the 
eCRF. For example, in a blinded study of an osmotic diuretic, the urine osmolality should not be 
revealed to the clinical investigator(s).  In some studies specific administrative data (e.g., code 
lists) might be exempt from review.  Data exempt from review should be listed (e.g., in a data 
management plan). 
 
2. 	 Modifications and Corrections During Clinical Investigator(s) Review of the 
eCRF 
 
To comply with the requirement to maintain accurate case histories,16 data elements might call 
for modification or correction during clinical investigator(s) review.  Either the clinical  
investigator(s) or an originator can enter the revised data element.  Modified and/or corrected 
data elements must have data element identifiers that reflect the date, time, originator, and reason 
for the change, and must not obscure previous entries.17  
 
If changes are made to the eCRF after the clinical investigator(s) has already signed, the changes 
should be reviewed and electronically signed by the clinical investigator(s).   
 
C. 	 Retention of Records by Clinical Investigator(s)   
 
 
The clinical investigator(s) should retain control of the records (i.e., completed and signed eCRF 
or certified copy of the eCRF). The clinical investigator(s) should provide FDA inspectors with 
access to the records that serve as the electronic source data.   
 
When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) 
must also retain the paper sources, or certified copies, for FDA review.18  Other records 
(electronic and paper) required to corroborate data in the eCRF (see section III.A.2.a) may also 
be requested by FDA during an inspection.19    
 
                                                 
14 21 CFR 312.62(b) and  812.140(a)(3). 
 
15 See the ICH E6  guidance;  see also 21 CFR  part  11, subpart C.
  
16 21 CFR 312.62(b) and  812.140(a)(3). 
 
17 21 CFR 11.10(e). 

18 21 CFR 312.62(b) and  812.140(a)(3). 
 
19 Ibid. 

  7 

    
1  D.  Data Access 
2 
 
3  Sponsors, CROs, data safety monitoring boards, and other authorized personnel can view the 
4  data elements in the eCRF before and after the clinical investigator(s) has electronically signed 
5  the completed eCRF.  We encourage viewing the data to allow early detection of study-related 
6  problems (e.g., safety concerns, protocol deviations) and problems with conducting the study 
7  (e.g., missing data, data discrepancies). 
8   
9  The sponsor should have a list (e.g., in a data management plan) of the individuals with 
10  authorized access to the eCRF. Only those individuals who have documented training and 
11  authorization should have access to the eCRF data.20  Individuals with authorized access should 
12  be assigned their own identification (log-on) codes and passwords.21  Log-on access should be 
13  disabled if the individual discontinues involvement during the study.   
14   
15  IV.   USE AND DESCRIPTION OF COMPUTERIZED SYSTEMS IN CLINICAL 
16  INVESTIGATIONS 
17   
18  Adequate controls should be in place to ensure confidence in the reliability, quality, and integrity 
19  of the electronic source data. The determination of whether a computer system used in a clinical  
20  investigation is suitable for its intended purpose might not be under the control of the clinical 
21  investigator(s) or sponsor (e.g., EHRs). The performance standards for these computer systems 
22  may be regulated by other authorities22 and under the control of, for example, healthcare 
23  providers or institutions. FDA does not intend to assess the compliance of EHRs with part 11. 
24   
25  Sponsors should include (e.g., in the protocol, data management plan, or investigational plan) 
26  information about the intended use of computerized systems used during a clinical investigation, 
27  a description of the security measures employed to protect the data, and a description or diagram  
28  of the electronic data flow. 
29   
30    
31   
                                                 
20 See 21 CFR 11.10(i). 
21 See 21 CFR  part 11.10(d). 
22 See 45 CFR part 170. 
  8 

    
32  REFERENCES 
33   
34  Code of Federal Regulations, Title 21 part 11:  Electronic Records; Electronic Signatures. 
35   
36  Code of Federal Regulations, Title 21  50.3:  Definitions. 
37   
38  Code of Federal Regulations, Title 21 part 312:  Investigational New Drug Application.  
39   
40  Code of Federal Regulations, Title 21 part 812:  Investigational Device Exemptions.   
41   
42  Code of Federal Regulations, Title 45 part 170:  Health Information Technology Standards, 
43  Implementation Specifications, and Certification Criteria and Certification Programs for 
44  Health Information Technology. 
45   
46  Food and Drug Administration, guidance for industry on Computerized Systems Used in 
47  Clinical Investigations, available at 
48  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default. 
49  htm.  
50   
51  Food and Drug Administration, ICH guidance for industry E6 Good Clinical Practice: 
52  Consolidated Guidance, available at 
53  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default. 
54  htm. 
55   
56   
57   
  9 

    
58 
  
59  GLOSSARY OF TERMS 
 
60 

 
61  The following is a list of terms and definitions used in this guidance: 

62 
  
63  Audit Trail: A process that captures details such as additions, deletions, or alterations of 

64  information in an electronic record without obscuring the original record.  An audit trail 

65  facilitates the reconstruction of  the course of such details relating to the electronic record.  

66 
  
67  Certified Copy: A copy (paper or electronic) of original information that has been verified, as
  
68  indicated by a dated signature, as an exact copy, having all of the same attributes and information 
 
69  as the original. 

70 
  
71  Clinical Investigator:  Investigator means an individual who actually conducts a clinical 

72  investigation (i.e., under whose immediate direction the drug is administered or dispensed to a 

73  subject). In the event an investigation is conducted by a team of individuals, the investigator is 

74  the responsible leader of the team.  Subinvestigator includes any other individual member of 

75  that team (21 CFR 312.3). 

76 
  
77  Computerized System: Includes computer hardware, software, and  associated documents (e.g., 

78  user manual) that create, modify, maintain, archive, retrieve, or  transmit in digital form 

79  information related to the conduct of a clinical investigation.   

80 
  
81  Data Element: A single observation associated with a subject in a clinical study.  Examples 

82  include birth date, white blood cell count, pain severity measure, and other clinical observations 

83  made and documented during a study.    

84 
  
85  Data Element Identifier: Information associated with a data element that includes the origin of 

86  the data element, the date and time of entry, and the identification number of the study subject to 

87  whom the data element applies.  Once set by the  computerized system, this value should not be 

88  alterable in any way. 
  
89 
  
90  Data Originator: Each data element is associated with an origination type that identifies the 

91  source of its capture in the eCRF. This could be a person, a computer system, a device, or an 

92  instrument that is authorized to enter, change, or transmit data elements into the eCRF (also 

93  sometimes known as an author).     

94 
  
95  Direct Entry: Initial recording of data into an electronic record.  Examples are the keying by an 

96  individual of original observations into a system, or automatic recording by a system of the 

97  output of a balance that measures a subjects body weight.    

98 
  
99  Electronic Case Report Form (eCRF): An auditable electronic record of information that 

100  generally is reported to the sponsor on each trial subject, according to a clinical investigation 

101  protocol. The eCRF enables clinical investigation data to be systematically captured, reviewed, 

102  managed, stored, analyzed, and reported. 

103 
  
  10 

    
104  Electronic Health Record (EHR):  An electronic record for healthcare providers to create, 
105  import, store, and use clinical information for patient care, according to nationally recognized 
106  interoperability standards. NOTE: The EHR has the following distinguishing features:  able to 
107  be obtained from multiple sources, shareable, interoperable, accessible to authorized parties.   
108   
109  Electronic Record:  Any combination of text, graphics, data, audio, pictorial, or other 
110  information representation in digital form that is created, modified, maintained, archived, 
111  retrieved, or distributed by a computer system (21 CFR 11.3(b)(6)).  
112   
113  Electronic Signature:  A computer data compilation of any symbol or series of symbols 
114  executed, adopted, or authorized by an individual to be the legally binding equivalent of the 
115  individual's handwritten signature (21 CFR 11.3(b)(7)).  
116   
117  Electronic Source Data:  Electronic source data are data initially recorded in electronic format.  
118   
119  Source Data:  All information in original records and certified copies of original records of 
120  clinical findings, observations, or other activities (in a clinical investigation) used for the 
121  reconstruction and evaluation of the trial. Source data are contained in source documents 
122  (original records or certified copies).   
123   
124  Transmit:  To transfer data within or among clinical study sites, contract research organizations, 
125  data management centers, sponsors, or to FDA; to transfer data, usually electronically.   
  11