Copy of Adding Study Subjects - ALT 10/2/2024 v2.2

You can add one or more study subject accrual records for any study to which you have been granted access.

If necessary, refer to Requesting Permission to Submit Accrual Data.

Study subject records include demographic data as well as the disease name.

How to Add Study Subject Records

1. Select the study you want to work with by following instructions in Searching for and Selecting Your Trials, and clicking the corresponding NCI Trial Identifier link. The Search Study Subject page appears.
    
2. Click Add Study Subject.
   The Add Study Subject panel appears right-aligned to the Study Subject page. (Screenshot below displays Subject accrual)
   
   

3. Enter the required demographic information in the text fields and drop-down lists. An asterisk (*) indicates a required field. 

4. The following table describes the valid values and formats for each field.

   Accrual Data Element	Definition	Required (R)/Conditional (C)		Accepted Values
   		Subject	Partial Subject
   Study Subject ID	Enter the unique Patient ID as per the lead organization or the study site where the subject is registered.	R	R	Any numeric or alphanumeric value
   Participating Site	Select the appropriate site from the drop-down list.	R	R
   Study Subject Registration Date	Enter the date that the subject was registered on the study.	R	R	User Interface format: MM/DD/YYYY REST format: YYYY-MM-DD Batch Upload format: YYYYMMDD
   Study Subject Birthdate (MM/YYYY)	Enter the subject's month and year of birth in the format MM/YYYY. Age is calculated by the difference between the Study Subject Registration Date and Study Subject Birthdate. The subject's age reported in CTRP cannot be greater than 120 years.	R		Accrual application format: MM/YYYY REST Services format: YYYY-MM-DD Batch Upload format: YYYYMM
   Study Subject Sex	Select the subject’s biological sex. If biological sex information is not available, select Unknown.	R		Male Female Unspecified Undifferentiated Unknown
   Study Subject Race	Select one or more values for race.  To select multiple races, select one race, and then press and hold the CTRL/CMD key as you select the other(s).	R		American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander Not Reported Unknown White
   Study Subject Ethnicity	Select a value for ethnicity.	R		Hispanic or Latino Not Hispanic or Latino Not Reported Unknown
   Study Subject Country	Select the study subject's country of residence.	R		CTRP is using the International Standards Organization country codes: https://www.iso.org/obp/ui/#search
   Study Subject Zip Code	Enter the study subject’s zip code.	C	C	Required if the Study Subject Country is the US, US territories and outlying islands. Must be in a 5 digit or 9 digit (DDDDD-DDDD) format
   Study Subject Disease Terminology	The accrual disease terminology selected at the trial level is inherited. Click the field to select a different disease terminology.	R		SDC ICD9 ICD10 ICD-O-3 Legacy Codes - CTEP
   Study Subject Disease	Click Look Up, and follow the instructions in Selecting Diseases for Study Subject Records. For ICD-O-3, CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.	R		Partial Subject: Disease is not required. ICD-O-3: If Disease is reported, Site is also required. Study Subject: Disease Code is required for all trial types. ICD-O-3: Disease and Site are required.
   Study Subject Disease Site (ICD-O-3)	Click Look Up, and follow the instructions in Selecting Sites for Study Subject Records Using ICD-O-3 Codes. Site Code information is available at: http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=57 CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.	C		Partial Subject: Site is not required. ICD-O-3: If Site is reported, Disease is also required. Study Subject: Site is required for all trial types.  ICD-O-3: Site and Disease are required.

5. Click Save.
   The study subject record appears in the List of Study Subjects.