Sub-Domain: Participant Characteristics
CRF: Behavioral History
CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
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C00709 | Tobacco cigarettes smoked daily average number | TobcoCigaretSmokedDlyAvgNum | Average number of cigarettes the participant/subject smokes daily (On the days you smoked cigarettes during the past 30 days, how many cigarettes did you smoke per day, on average?) | Average number of cigarettes the participant/subject smokes daily (On the days you smoked cigarettes during the past 30 days, how many cigarettes did you smoke per day, on average?) | Average number of cigarettes smoked per day | Less than one cigarette per day;1 cigarette per day;2 to 5 cigarettes per day;6 to 15 cigarettes per day (about 1/2 pack);16 to 25 cigarettes per day (about 1 pack);26 to 35 cigarettes per day (about 1 1/2 packs);More than 35 cigarettes per day (about 2 packs or more);Unknown | Less than one cigarette per day;1 cigarette per day;2 to 5 cigarettes per day;6 to 15 cigarettes per day (about ½ pack);16 to 25 cigarettes per day (about 1 pack);26 to 35 cigarettes per day (about 1 ½ packs);More than 35 cigarettes per day (about 2 packs or more);Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
PhenX Toolkit: https://www.phenxtoolkit.org/index.php - Protocol 1: Tobacco - 30-Day Quantity and Frequency (Adolescent Protocol) #030801 | Adult;Pediatric | Core | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3170853 | ||||||||||||||||||||||||||||
C60112 | Electronic simulated cigarette use frequency past 30 day category | ElecSimCigUseFrqPst30DyCat | Category of frequency of use of electronic cigarettes or similar devices by the subject/participant in the past 30 days. | Category of frequency of use of electronic cigarettes or similar devices by the subject/participant in the past 30 days. | During the last 30 days, on how many days (if any) have you used an electronic vaporizer such as an e-cigarette? | 0 days;3-5 days;1 or 2 days;6-9 days;10-19 days;20-30 days | 0 days;3-5 days;1 or 2 days;6-9 days;10-19 days;20-30 days | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 16:34:12.0 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
|||||||||||||||||||||||||||||||
C00710 | Tobacco current use indicator | TobcoUseCurntInd | Indicator for whether the participant/subject regularly uses tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) at the present time. | Indicator for whether the participant/subject regularly uses tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) at the present time. | Current tobacco use? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-20 10:21:25.65 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3170060 | SU | TOBAC_CURR_SUNCF |
Never Current Former Usage |
Tobacco Current Usage |
Does the subject currently use tobacco? |
QVAL; SUENRF; SUENRTPT; SUOCCUR; SUSTRF; SUSTRTPT | Char | Check the appropriate box to indicate if the subject has ever used/consumed tobacco/alcohol/caffeine, currently consumes tobacco/alcohol/caffeine, or formerly used/consumed tobacco/alcohol/caffeine. | (NCF) |
CURRENT |
Prompt | Checkbox | ||||||||||||||||
C00700 | Alcohol use stopped age value | AlcUseStopAgeVal | Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking | Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking | Age quit drinking | Numeric Values |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Free-Form Entry |
0 | 120 | year | 2008448 | |||||||||||||||||||||||||||
C00711 | Tobacco prior use indicator | TobcoPriorUseInd | Indicator of the participant's/subject's past regular tobacco (e.g., cigarettes, cigars, chewing tobacco or pipe) use prior to the past 12 months | Indicator of the participant's/subject's past regular tobacco (e.g., cigarettes, cigars, chewing tobacco or pipe) use prior to the past 12 months | Past tobacco use? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Supplemental - Highly Recommended based on study type, disease stage and disease type |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-20 10:21:25.65 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3170080 | TOBAC_PRIO_SUNCF |
Never Current Former Usage |
Tobacco Prior Usage |
Has the subjet ever used tobacco? |
QVAL; SUENRF; SUENRTPT; SUOCCUR; SUSTRF; SUSTRTPT | Char | Check the appropriate box to indicate if the subject has ever used/consumed tobacco/alcohol/caffeine, currently consumes tobacco/alcohol/caffeine, or formerly used/consumed tobacco/alcohol/caffeine. | (NCF) |
FORMER |
Prompt | Checkbox | |||||||||||||||||
C00701 | Tobacco use stopped age value | TobcoUseStopAgeVal | Age in years when participant/subject stopped using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) | Age in years when participant/subject stopped using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) | Age stopped tobacco use | Numeric Values |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Free-Form Entry |
0 | 120 | year | 2524471 | |||||||||||||||||||||||||||
C00712 | Subscribed drug or substance illicitly used category | SbscrbdDrgSubIllctUseCat | Category of illegal drugs, prescription, or over-the-counter drugs subscribed by the participant/subject, and used for purposes other than those for which they are meant to be used, or in large amounts | Category of illegal drugs, prescription, or over-the-counter drugs subscribed by the participant/subject, and used for purposes other than those for which they are meant to be used, or in large amounts | If YES, specify illicit drug type(s) used | Sedatives (e.g., sleeping pills, barbiturates, Seconal, Quaaludes, or Chloral Hydrate);Tranquilizers or anti-anxiety drugs (e.g., Valium, Librium, muscle relaxants, or Zanax);Painkillers (e.g., Codeine, Darvon, Percodan, Dilaudid, or Demerol);Stimulants (e.g., Preludin, Benzedrine, Methadrine, uppers, or speed);Marijuana, hash, THC, or grass;Cocaine or crack;Hallucinogens (e.g., Ecstasy, LSD, mescaline, psilocybin, PCP, angel dust, or peyote);Inhalants or Solvents (e.g., amyl nitrate, nitrous oxide, glue, toluene, or gasoline;Heroin;Other, specify (e.g., Methadone, Elavil, steroids, Thorazine, or Haldol) | Sedatives (e.g., sleeping pills, barbiturates, Seconal, Quaaludes, or Chloral Hydrate);Tranquilizers or anti-anxiety drugs (e.g., Valium, Librium, muscle relaxants, or Zanax);Painkillers (e.g., Codeine, Darvon, Percodan, Dilaudid, or Demerol);Stimulants (e.g., Preludin, Benzedrine, Methadrine, uppers, or speed);Marijuana, hash, THC, or grass;Cocaine or crack;Hallucinogens (e.g., Ecstasy, LSD, mescaline, psilocybin, PCP, angel dust, or peyote);Inhalants or Solvents (e.g., amyl nitrate, nitrous oxide, glue, toluene, or gasoline;Heroin;Other, specify (e.g., Methadone, Elavil, steroids, Thorazine, or Haldol) | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Supplemental - Highly Recommended based on study type, disease stage and disease type |
PhenX Toolkit - Substances - Lifetime Use Protocol #031100: https://www.phenxtoolkit.org/index.php | Adult;Pediatric | Supplemental - Highly Recommended | 3.00 | 2013-07-22 09:34:41.527 | Behavioral History | Participant Characteristics | General Health History |
Multiple Pre-Defined Values Selected |
3171797 | ||||||||||||||||||||||||||||
C00702 | Alcohol use started age value | AlcUseStrtAgeVal | Age in years when participant/subject started ingesting alcoholic beverages, including social drinking | Age in years when participant/subject started ingesting alcoholic beverages, including social drinking | Age started drinking | Numeric Values |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Free-Form Entry |
0 | 120 | year | 2008447 | |||||||||||||||||||||||||||
C00713 | Drug or substance current illicit use indicator | DrgSubstCurrntIllicitUseInd | Indicator of participant's/subject's use of illegal drugs, prescription or over-the-counter drugs in the past year for purposes other than those for which they are meant to be used, or in large amounts | Indicator of participant's/subject's use of illegal drugs, prescription or over-the-counter drugs in the past year for purposes other than those for which they are meant to be used, or in large amounts | Current drug user | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Supplemental - Highly Recommended based on study type, disease stage and disease type |
No references available | Adult;Pediatric | Supplemental - Highly Recommended | 3.00 | 2013-07-20 10:21:25.65 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171724 | ||||||||||||||||||||||||||||
C00703 | Tobacco use started age value | TobcoUseStrtAgeVal | Age in years when participant/subject started using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) | Age in years when participant/subject started using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) | Age started tobacco use | Numeric Values |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Free-Form Entry |
0 | 120 | year | 2178045 | |||||||||||||||||||||||||||
C00714 | Behavioral history assessment date and time | BehavrlHistAssmtDateTime | Date (and time, if applicable and known) the participant/subject behavioral history was taken. | Date (and time, if applicable and known) the participant/subject behavioral history was taken. | Date behavioral history taken | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Free-Form Entry |
3170040 | ||||||||||||||||||||||||||||||
C00704 | Alcohol drinking day average drinks consumed range | AlcDrinkingDayAvgDrinks | The counted number of drinks containing alcohol consumed by the participant/subject on a typical day when he/she is drinking. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another, so the most common alcoholic beverages likely to be consumed will be defined as well as quantity of each that constitutes a drink (approximately 10 grams of pure ethanol). For example, one bottle of beer (330 ml at 5% ethanol), a glass of wine (140 ml at 12% ethanol), and a shot of spirits (40 ml at 40% ethanol) represent a standard drink of about 13 g of ethanol. | The counted number of drinks containing alcohol consumed by the participant/subject on a typical day when he/she is drinking. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another. | How many alcoholic drinks do you have on a typical day when you are drinking | 1 or 2;3 or 4;5 or 6;7, 8, or 9;10 or more;Unknown;1 or 2;3 or 4;5 or 6;7, 8, or 9;10 or more;Unknown | 1 or 2;3 or 4;5 or 6;7, 8, or 9;10 or more;Unknown;1 or 2;3 or 4;5 or 6;7, 8, or 9;10 or more;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
Question is from the Alcohol Use Disorders Identification Test (AUDIT) - http://www.who.int/substance_abuse/activities/sbi/en/ | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171647 | ||||||||||||||||||||||||||||
C00719 | Tobacco product used type | TobcoProdctUsedTyp | Type of tobacco product (e.g., cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject | Type of tobacco product (e.g., cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject | Type(s) of tobacco used | Filtered cigarettes;Non-filtered cigarettes;Low tar cigarettes;Cigars;Pipes;Chewing tobacco;Other, specify | Filtered cigarettes;Non-filtered cigarettes;Low tar cigarettes;Cigars;Pipes;Chewing tobacco;Other, specify | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 3.00 | 2013-07-20 10:21:25.65 | Behavioral History | Participant Characteristics | General Health History |
Multiple Pre-Defined Values Selected |
3179449v1 | ||||||||||||||||||||||||||||
C00705 | Alcohol current use indicator | AlcCurntUseInd | Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months | Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months | Current drinker? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171540 | ||||||||||||||||||||||||||||
C00730 | Alcohol use frequency | AlcUseFreq | The frequency of consumption of alcohol by the participant. | The frequency of consumption of alcohol by the participant. | How often do you have a drink containing alcohol? | Monthly or less;2 to 4 times a month;2 to 3 times a week;4 or more times a week;Unknown;Never | Monthly or less;2 to 4 times a month;2 to 3 times a week;4 or more times a week;Unknown;Never | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Supplemental - Highly Recommended based on study type, disease stage and disease type |
Question is from the Alcohol Use Disorders Identification Test (AUDIT) - http://www.who.int/substance_abuse/activities/sbi/en/ | Adult;Pediatric | Supplemental - Highly Recommended | 3.00 | 2013-07-18 16:35:19.49 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171627 | ||||||||||||||||||||||||||||
C00706 | Alcohol prior use indicator | AlcPriorUseInd | Indicator of the participant's/subject's alcohol consumption prior to the past 12 months | Indicator of the participant's/subject's alcohol consumption prior to the past 12 months | Past drinker | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171578 | ||||||||||||||||||||||||||||
C18670 | Subscribed drug or substance illicitly used other text | SbscrbdDrgSubIllctUseOTH | The free-text field related to 'Drug or substance illicitly used category' specifying other text. Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts | Drug or substance illicitly used category' specifying other text. Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts | Other, specify | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Supplemental - Highly Recommended based on study type, disease stage and disease type |
PhenX Toolkit - Substances - Lifetime Use Protocol #031100: https://www.phenxtoolkit.org/index.php | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Behavioral History | Participant Characteristics | General Health History | 4000 |
Free-Form Entry |
3171797 | |||||||||||||||||||||||||||||
C00707 | Alcohol consume six or more drinks frequency | AlcConsume6MoreDrinkFreq | The rate of occurrence for when the participant/subject consumes six or more drinks containing alcohol on one occasion. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another, so the most common alcoholic beverages likely to be consumed will be defined as well as quantity of each that constitutes a drink (approximately 10 grams of pure ethanol). For example, one bottle of beer (330 ml at 5% ethanol), a glass of wine (140 ml at 12% ethanol), and a shot of spirits (40 ml at 40% ethanol) represent a standard drink of about 13 g of ethanol. | The rate of occurrence for when the participant/subject consumes six or more drinks containing alcohol on one occasion. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another. | How often do you have six or more drinks on one occasion? | Never;Less than monthly;Monthly;Weekly;Daily or almost daily;Unknown | Never;Less than monthly;Monthly;Weekly;Daily or almost daily;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
Question is from the Alcohol Use Disorders Identification Test (AUDIT) - http://www.who.int/substance_abuse/activities/sbi/en/ | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171659 | ||||||||||||||||||||||||||||
C18770 | Tobacco product used other text | TobcoProdctUsedOTH | The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject | The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject | Other, specify | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Core | 1.00 | 2014-05-27 13:34:46.0 | Behavioral History | Participant Characteristics | General Health History | 4000 |
Free-Form Entry |
3170860 | |||||||||||||||||||||||||||||
C00708 | Alcohol use related to hospitalization indicator | AlcUseRelatedHospInd | Indicator of whether the participant/subject has been hospitalized for an alcohol-related problem (i.e., esophageal varices, delirium tremens (DTs), cirrhosis and others) | Indicator of whether the participant/subject has been hospitalized for an alcohol-related problem (i.e., esophageal varices, delirium tremens (DTs), cirrhosis and others) | Have you ever been hospitalized for an alcohol-related problem | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
History can be obtained from participant/ subject, family member, friend, or chart/ medical record. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 14:26:06.9 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |
3171677 | ||||||||||||||||||||||||||||
C60111 | Electronic simulated cigarette ever use frequency category | ElecSimCigEvrUseFrqCat | Category of frequency of use of electronic simulated cigarettes or similar devices by the subject/participant. | Category of frequency of use of electronic simulated cigarettes or similar devices by the subject/participant. | Have you ever used an electronic vaporizer such as an e-cigarette? | Never;Once or twice;Regularly in the past;Regularly now;Occasionally but not regularly | Never;Once or twice;Regularly in the past;Regularly now;Occasionally but not regularly | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-01-14 16:24:33.0 | Behavioral History | Participant Characteristics | General Health History |
Single Pre-Defined Value Selected |