Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_inv_drugs.
2. cc_protocol_info has 0-multiple cc_protocol_inv_devices.
3. cc_protocol_info has 0-multiple cc_protocol_exclusions.
4. cc_protocol_info has 0-multiple cc_protocol_consents.
5. cc_protocol_info has 0-multiple cc_protocol_keywords.
6. cc_protocol_info has 0-multiple cc_protocol_pi_keywords.
7. cc_protocol_info has a principal investigator and an information contact whose biographical data are contained in cc_researcher_info.
8. cc_protocol_info has 0-multiple cc_protocol_alias_info.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Owned Key protocol_id Protocol ID is year and sequence number. IE, the protocol id for protocol 96-C-0023 is 960023.
int Owned Non-key title Protocol Title text
Owned Non-key abbrv_title Abbreviated Title/Short Title for protocol.
varchar(30) Owned Non-key
principal_inv_id Principal Investigator ID. numeric(9)
Foreign Non-key info_contact_id Information Contact ID. This field is used by the web pages to determine who requests for info should go to. Requests are filtered through CC Communications.
numeric(9) Foreign Non-key research_type
Research Type indicates clinical versus screening.
varchar(30) Owned Non-key research_phase
Research Phase for Protocol. Entries are I, II, III, IV or N/A.
char(4) Owned Non-key protocol_type
Protocol Type. I.E. Active, Inactive Terminated, Active Follow-Up.
char(30)
Owned Non-key initial_approval_date
Initial Approval Date of protocol provided by OD, CC.
datetime
Owned Non-key termination_date
Date protcol was terminated.
datetime
Owned Non-key precis
Precis/Study summary for protocol.
text
Owned Non-key hstat_access
Identifies whether protocol can be made available to public protocol web site. If No, then pi was given approval by MRD Director to leave off system.
char(3)
Owned Non-key gender
Gender inclusions for protocol. Can be Male, Female, Male & Female.
varchar(13)
Owned Non-key median_sub_age
Age range in which most people fall under for protocol. I.E. 0-4, 5-17, 18-32. Exact entries must be looked up.
varchar(10)
Owned Non-key icd9_disease_code
ICD( Disease Code in which Protocol falls under.
char(80)
Owned Non-key new_drug_approval
Indicates whether drugs exist for protocol or not. Not inclusive of all drugs only those reported on review.
char(3)
Owned Non-key new_device_approval
Indicates whether investigational devices exist. Not inclusive of all devices only those reported on review.
char(3)
Owned Non-key pi_last_modified_date
Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime
Owned Non-key pi_inactive_date
Protocols are made inactive when they change institute.
datetime
Owned Non-key pi_status
N indicates active, y indicates inactive.
char(1)
Owned Non-key principal_branch
Principal Branch, Used to sort protocols
char(2)
Owned Non-key principal_inst
Principal Institute, Used to sort protocols
char(2)
Owned Non-key accrual_inst
Accrual Institute
char(2)
Owned Non-key accrual_branch
Accrual Branch, Used to sort protocols
char(2)
Owned Non-key referral_flag
Referral Letter Required For Inclussion To Protocol
char(2)
Owned Non-key Normal Control Flag
Indicates Normal Control Protocol
char(2)
Owned Non-key irb_ceiling
Ceiling of number of subjects
char(2)
Owned Non-key reported_subjects_to_date
Number of Subjects Reported By PI
char(2)
Owned Non-key
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_alias_info.
Base Name Attribute Definition
Column Datatype Attribute Type
protocol_id Protocol ID is year and sequence number. IE, the protocol id for protocol 96-C-0023 is 960023.
int Owned Key protocol_alias Alias or synonym for protocol.
varchar(30) Owned Key
organization Organization that defined the alias.
varchar(30) Owned Non-key
pai_last_modified_date Last date this entry was updated in the system.
datetime Owned Non-key
date_added Date Alias was added to system.
datetime Owned Non-key
who_added Who Added Alias.
varchar(10) Owned Non-key who_modified Who Modified alias.
varchar(10) Owned Non-key
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_consents.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key arm_id ID of consent used to search and find a given consent.
varchar(15) Owned Key
arm_title Title of consent provided by MRD.
varchar(80) Owned Non-key
original_filename Original filename for arm provided by MRD.
varchar(80) Owned Non-key
pdf_filename PDF Filename for protocol consent.
varchar(30) Owned Non-key
pc_last_modified_date Last date this entry was updated in the system.
datetime Owned Non-key
pc_status Status of consent is used to determine if one or more consents of a protocol are inactive.
char(1) Owned Non-key
consent_modified Consent Modified flag to indicate MRD changed consent and pdf of consent should have been upload. Field used for auditing for protocol consents on the web system.
char(3) Owned Non-key
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_exclusions.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key exclusion_type Exclusion indicate criteria in which are used to exclude those to participate in a protocol by either race or gender. Examples of exclusion are: Males, Females, Whites (not of hispanic origin).
varchar(30) Owned Key
pe_last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_inv_devices.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key dev_standard_name Standard name provided by MRD. All devices are given standard names to increase the efficiency for searching.
varchar(80) Owned Key
pidev_last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_inv_drugs.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key drg_standard_name Standard name provided by MRD. All drugs are given standard names to increase the efficiency for searching.
varchar(80) Owned Key
pidrg_last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_keywords.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key keyword Keyword extracted from precis, title, drugs, devices based on using space as a dilimiter.
varchar(255) Owned Non-key
frequency Frequency of a keyword for a given protocol.
smallint Owned Non-key
Table: cc_protocol_pi_keywords
Description: cc_protocol_pi_keywords contains information relating to the keywords of a protocol. These keywords are identified by the principal investigator of a protocol. Five keywords can be entered per review with MRD keeping only the first 10 per protocol.
Relationships:
1. cc_protocol_info has 0-multiple cc_protocol_pi_keywords.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key keyword Keyword provided by PI. Limited to 5 per review, ten total in MRD's database.
varchar(80) Owned Key
ppk_last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Relationships:
Relationships:
Relationships:
Relationships:
Relationships:
Relationships:
1. cc_protocol_info has a principal investigator and an information contact whose biographical data are contained in cc_researcher_info.
Note: Principal Investigators and Information Contacts are entered based on fullname, institute, and branch. The result is that multiple entries may be possible for the same investigator. This will be reviewed and corrected.
Base Name Attribute Definition
Column Datatype Attribute Type
Base Name Attribute Definition
Column Datatype Attribute Type
ri_sequence_id Researcher unique identification number.
numeric(9) Owned Key ri_last_name Researcher Last Name.
varchar(30) Owned Non-key
ri_first_name Researcher First Name.
varchar(30) Owned Non-key
ri_middle_initial Researcher Middle Initial
char(1) Owned Non-key
ri_suffix Researcher suffix.
varchar(9) Owned Non-key
ri_prof_designation Researcher Professional Designation.
varchar(9) Owned Non-key
ri_institute Researcher Institute affiliation.
char(2) Owned Non-key
ri_branch Researcher branch affiliation.
char(2) Owned Non-key
ri_office_address Researcher NIH Address for internal researchers. Street Address1 for external researchers.
varchar(30) Owned Non-key
ri_office_phone Researcher Office Phone.
varchar(14) Owned Non-key
ri_office_fax Researcher Office Fax.
varchar(14) Owned Non-key
ri_email_address Researcher email address.
varchar(80) Owned Non-key
ri_full_name Researcher Full Name.
varchar(60) Owned Non-key
ri_last_date_modified Last date this entry was updated in the system.
datetime Owned Non-key
ri_office_address_addition Street Address 2.
varchar(30) Owned Non-key
ri_office_address_city City
varchar(30) Owned Non-key
ri_office_address_state State
varchar(30) Owned Non-key
ri_office_address_zip Zip
varchar(10) Owned Non-key ri_speciality Speciality of Researcher varchar(30)
Owned Non-key rni_nih_id NIH Research ID char(18)
Owned Non-key ri_office_address_country Country Address char(18)
Owned Non-key Table: cc_researcher_info
Description: cc_researcher_nih_info contains address information for principal investigators and information contacts for protocols.
1. cc_protocol_info has a principal investigator and an information contact whose biographical data are contained in cc_researcher_info.
1. cc_researcher_info has address information contained in cc_researcher_nih_info.
Base Name Attribute Definition
Column Datatype Attribute Type
rni_nih_id NIH Research ID char(18)
Owned Non-key rni_full_Address NIH Full Address text
Owned Non-key rni_quick_address NIH Research ID char(10)
Owned Non-key SCHEDULED ADDITITIONS
Table: cc_protocol_protocol_keywords_by_field
Description: cc_protocol_keywords_by_field contains information relating to the keywords of a protocol.
These keywords are parsed by the perl script used to load data.
1. cc_protocol_info has 0-multiple cc_protocol_keywords_by_field.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key keyword Sequence ID
varchar(255) Owned Key
sequence_id Keyword
numeric(9) Owned Key
field_no Field Number
smallint Owned Key
frequency Frequency of word in field
smallint Owned Key
last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Table: cc_protocol_fields
Description: cc_protocol_fields contains identifies the fields of a protocol in which keywords can be extracted.
1. cc_protocol_keywords_by_field has 1 cc_protocol_fields.
Base Name Attribute Definition
Column Datatype Attribute Type
pf_field_id Field ID
smallint Primary Key pf_description Name of field
varchar(30) Owned Key
Table: cc_protocol_recruit_keywords
Description: cc_protocol_recruit_keywords contains information relating to the keywords of a protocol.
1. cc_protocol_info has 0-multiple cc_protocol_recruit_keywords.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key prk_keyword Keyword
varchar(80) Owned Key
prk_last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Table: cc_protocol_citations
Description: cc_protocol_citations contains information relating to three citations selected by the PI.
1. cc_protocol_info has 0-multiple cc_protocol_citations.
Base Name Attribute Definition
Column Datatype Attribute Type
nih_protocol_id The protocol number assigned by the Protocol Services Section, MRD. Number is year-institute-sequence number.
varchar(20) Foreign Key pcc_sequenc_id Sequence ID
numeric(15) Primary Key
pcc_journ_abb Journal Abbreviation
varchar(80) Owned Non-key
pcc_author_last_name Author Last Name
varchar(80) Owned Non-key
pcc_published_year Year Published
varchar(10) Owned Non-key
pcc_article_title Article Title
varchar(255) Owned Non-key
pcc_journal_vol Journal Volume
varchar(10) Owned Non-key
pcc_article_first_page First Page
varchar(10) Owned Non-key
pcc_last_modified_date Date modified in system. This date identifies the last date the protocol information was verified and updated.
datetime Owned Non-key
Return to Main Table of Contents CDR
National Institutes of Health (NIH)
Warren Grant Magnuson Clinical Center (CC)
Information Systems Department (ISD)
Bethesda, Maryland 20892
Last modified 6/11/99