CDR Protocol Specifications: MRD File Format

Clinical Data Repository (CDR)

Protocol Specifications
National Institutes of Health
Warren G. Magnuson Clinical Center
Information Systems Department
Revised on June 11, 1999
Version 1.4

Data Source File Format For Protocol Data

Data Source format of file provided by the MRD. Protocol data is provided on a daily basis with the complete protocol file from MRD's PROTRAK database provided. The perl program nloaddb.pl parses this file which loads the data into the Protocol Tables inside the COMMON Database.

#0 Protocol Number Number of Protocol

#1 Protocol Title Title of Protocol

#2 Protocol Abbreviated Title Protocol Short Title

#3 Acrrual Institute Institute Acronym of Sponsoring Institute

#4 Acrual Branch Branch Abbreviation of Sponsoring Branch

#5 PI ID Number MRD Prinicipal Investigator (PI) ID Number

#6 PI Last Last name of Prinicipal Investigator (PI)

#7 PI First First name of PI

#8 PI MI Middle name of PI

#9 PI Suffix Suffix of PI

#10 PI Degree Degree of PI

#11 PI Inst Institute of PI

#12 PI Branch Branch of PI

#13 PI Address Address of PI

#13 PI Quick Address Building/Room Address of PI

#15 PI Phone Phone number of PI

#16 PI Fax Fax Number of PI

#17 PI Email Email of PI

#18 PI FullName Fullname of PI

#19 Study Contact ID Number MRD Study Contact (SC) ID Number

#20 Study Contact Last Last name of Study Contact (SC)

#21 Study Contact First First name of (SC)

#22 Study Contact MI Middle name of (SC)

#23 Study Contact Suffix Suffix of (SC)

#24 Study Contact Degree Degree of (SC)

#25 Study Contact Inst Institute of (SC)

#26 Study Contact Address Address of (SC)

#27 Quick Address of (SC) Quick Address of (SC)

#28 Study Contact Phone Phone number of (SC)

#29 Study Contact Fax Fax Number of (SC)

#30 Study Contact Email Email of (SC)

#31 Study Contact FullName Fullname of Study Contact (SC)

#32 Precis Study summary

#33 Research Type Research Type (Clinical Trial, Natural History, Training, Screening)

#34 Research Phase Phase of research study

#35 Protocol Type Curent accrual status (Active, Followup Only, Terminated)

#36 Gender Gender (Male, Femal, Male & Female)

#37 Median Age Age range of patient population

#38 ICD9 Disease Category Disease category for protocol

#39 IRB Ceiling Investigation Review Borad Ceiling of Subjects

#40 Subjects To Date Subjects To Date Reported By PI

#41 Approval Date Date of Initial Approval

#42 Termination Date Date of Termination

#43 Eligibility Criteria Eligibility Criteria (Exclusions and Inclusions)

#44 Protocol Summary Layman's Summary

#45 Special Instructions Special Instructions

#46 Referral Letter Required Referral Letter Required

#47 Normal Control Flag Normal Control Flag

#48 HSTAT Access Available on HSTAT

#49 Drug Approval Approval for Investigational Drugs

#50 Device Approval Approval for Investigational Devices

#0 Number of Exclusions Number of Gener/Ethnicity Exclusions

#1 Exclusions Gener/Ethnicity Exclusions

#0 Number of Citations Number of Citations (PI Can Only Submit A Max Of 3

#1 Abbreviated Journal Title Abbreviated Journal Title

#2 Author Last Name Author Last Name

#3 Article Title Article Title

#4 Volume Volume of Journal

#4 First Page First Page Of Article

#0 Number of Recruitment Keywords Keywords identified by PI

#1 Recruitment Keywords Keywords

#0 Number of PI Keywords Keywords identified by PI (5 per review, limit of 10. Keyword cannot be in title or precis)

#1 PI Keywords Keywords

#0 Number of Drugs Number of drugs reports

#1 Drug Name Standard name provided to drug

#0 Number of Devices Number of devices reports

#1 Device Name Standard name provided to devices

#0 Number of Consent Arms Number of different consents

#1 Consent Arm Description Description of Consent

#2 Consent Arm Filename Filename of PDF Consent File

#3 Consent Active or Not Status of Consent

#4 Consent Modified Date Consent was modified

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National Institutes of Health (NIH)
Warren Grant Magnuson Clinical Center (CC)
Information Systems Department (ISD)
Bethesda, Maryland 20892

Last modified 6/11/99

#0	Protocol Number	Number of Protocol
#1	Protocol Title	Title of Protocol
#2	Protocol Abbreviated Title	Protocol Short Title
#3	Acrrual Institute	Institute Acronym of Sponsoring Institute
#4	Acrual Branch	Branch Abbreviation of Sponsoring Branch
#5	PI ID Number	MRD Prinicipal Investigator (PI) ID Number
#6	PI Last	Last name of Prinicipal Investigator (PI)
#7	PI First	First name of PI
#8	PI MI	Middle name of PI
#9	PI Suffix	Suffix of PI
#10	PI Degree	Degree of PI
#11	PI Inst	Institute of PI
#12	PI Branch	Branch of PI
#13	PI Address	Address of PI
#13	PI Quick Address	Building/Room Address of PI
#15	PI Phone	Phone number of PI
#16	PI Fax	Fax Number of PI
#17	PI Email	Email of PI
#18	PI FullName	Fullname of PI
#19	Study Contact ID Number	MRD Study Contact (SC) ID Number
#20	Study Contact Last	Last name of Study Contact (SC)
#21	Study Contact First	First name of (SC)
#22	Study Contact MI	Middle name of (SC)
#23	Study Contact Suffix	Suffix of (SC)
#24	Study Contact Degree	Degree of (SC)
#25	Study Contact Inst	Institute of (SC)
#26	Study Contact Address	Address of (SC)
#27	Quick Address of (SC)	Quick Address of (SC)
#28	Study Contact Phone	Phone number of (SC)
#29	Study Contact Fax	Fax Number of (SC)
#30	Study Contact Email	Email of (SC)
#31	Study Contact FullName	Fullname of Study Contact (SC)
#32	Precis	Study summary
#33	Research Type	Research Type (Clinical Trial, Natural History, Training, Screening)
#34	Research Phase	Phase of research study
#35	Protocol Type	Curent accrual status (Active, Followup Only, Terminated)
#36	Gender	Gender (Male, Femal, Male & Female)
#37	Median Age	Age range of patient population
#38	ICD9 Disease Category	Disease category for protocol
#39	IRB Ceiling	Investigation Review Borad Ceiling of Subjects
#40	Subjects To Date	Subjects To Date Reported By PI
#41	Approval Date	Date of Initial Approval
#42	Termination Date	Date of Termination
#43	Eligibility Criteria	Eligibility Criteria (Exclusions and Inclusions)
#44	Protocol Summary	Layman's Summary
#45	Special Instructions	Special Instructions
#46	Referral Letter Required	Referral Letter Required
#47	Normal Control Flag	Normal Control Flag
#48	HSTAT Access	Available on HSTAT
#49	Drug Approval	Approval for Investigational Drugs
#50	Device Approval	Approval for Investigational Devices
#0	Number of Exclusions	Number of Gener/Ethnicity Exclusions
#1	Exclusions	Gener/Ethnicity Exclusions
#0	Number of Citations	Number of Citations (PI Can Only Submit A Max Of 3
#1	Abbreviated Journal Title	Abbreviated Journal Title
#2	Author Last Name	Author Last Name
#3	Article Title	Article Title
#4	Volume	Volume of Journal
#4	First Page	First Page Of Article
#0	Number of Recruitment Keywords	Keywords identified by PI
#1	Recruitment Keywords	Keywords
#0	Number of PI Keywords	Keywords identified by PI (5 per review, limit of 10. Keyword cannot be in title or precis)
#1	PI Keywords	Keywords
#0	Number of Drugs	Number of drugs reports
#1	Drug Name	Standard name provided to drug
#0	Number of Devices	Number of devices reports
#1	Device Name	Standard name provided to devices
#0	Number of Consent Arms	Number of different consents
#1	Consent Arm Description	Description of Consent
#2	Consent Arm Filename	Filename of PDF Consent File
#3	Consent Active or Not	Status of Consent
#4	Consent Modified	Date Consent was modified

Clinical Data Repository (CDR)

Protocol Specifications National Institutes of Health Warren G. Magnuson Clinical Center Information Systems Department Revised on June 11, 1999 Version 1.4

Data Source File Format For Protocol Data

Return to Main Table of Contents CDR

Protocol Specifications
National Institutes of Health
Warren G. Magnuson Clinical Center
Information Systems Department
Revised on June 11, 1999
Version 1.4