cpcrn cohort roadmap - NIDDK Central Repository

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NIDDK Data Repository
10/2010
CPCRN Data Archive
The CHRONIC PROSTATITIS COLLABORATIVE RESEARCH NETWORK (CPCRN) data
archive contains the study protocol and related descriptive documentation; study forms; and data
collected by the study.
The data files are organized into the following four directories:
1. Documentation
2. Forms
3. Data
4. Dataset Integrity Check
1. Documentation Directory
The Documentation directory contains documentation of the CPCRN protocol and descriptive
documentation, including:


MOP: a subdirectory containing the Manual of Operation (MOP)
o Cohort_Mop.pdf --- the manual of operation for the Chronic Prostatitis Cohort
(CPC) Study
o cpc-cp.mop.doc --- the manual of operation for the Chronic Prostatitis Cohort
Control Patients (CPC-CP) substudy
Protocol: a subdirectory containing the following seven files:
o CPCprotocol2edition.pdf: the CPC study protocol
o cpc_control.doc: the CPC Control Group study protocol
o CPC Visit Schedule Amendment.pdf: the Visit Schedule Amendment
o ProtocolAmendmentsJan99.pdf: the Protocol Amendment
o appendices.doc: the original protocol appendices
o appendixa.doc: the protocol appendix A Amendments
o appendixfandglab2.doc the protocol appendix F and G Amendments
2. Forms Directory
The Forms directory contains the 42 forms used for data collection. The forms are described in
Tables 1.
Table 1: Study Forms
Form
bcchk
bcrem
briefclinic
cmed
Version 1.0
Description
Brief Clinic Contact Checklist
Brief Clinic Reminder
Brief Clinic Contact Checklist
Concomitant Medications
1
NIDDK Data Repository
comp
cont
cpcrn_cohort_data_
entry_forms
def
dpcs
ecchk
ecrem
epi
exam
excl
extensiveclinic
fgtm
fgtsc
howto
ihc
incl
info
lab
med
miss
phone
prior
ref
rein
rus
schk
scr
screening
semen
serum
swab
sxind
tchk
telephone
track
trem
uro
void
with
10/2010
Patient Completion
Patient Contact Information
CPCRN Cohort Data Entry Forms
Deferral Checklist
Data Processing Cover Sheet
Extensive Clinic Contact Checklist
Extensive Clinic Reminder
Epidemiologic History
Physical Exam
Exclusion Checklist
Extensive Clinic Contact Checklist
Four Glass Test Microscopy
Four Glass Test Specimen Cultures
How To Complete Your Voiding Log
Interim Health Care
Inclusion Checklist
Uroflow Study - Patient Information
Lab Tracking Log
Medical History
Missing Contact
Telephone Log
Prior Treatments and Procedures
Patient Refusal Log
Patient Reinstatement
Resource Utilization Survey
Screening Contact Checklist
Screening Confirmation
Screening Contact Checklist
Semen Sample
Serum Sample
Urethral Swab
Symptom Index
Telephone Contact Checklist
Telephone Interview Form that combines the “Telephone
Contact Checklist” and “Symptom Index” Forms.
Status Tracking Log
Telephone Interview Reminder
Uroflow Study
Voiding Log
Patient Withdrawal
3. Data Directory
The Data directory contains the CPCRN datasets organized in two subdirectories:
3.1 Datasets
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NIDDK Data Repository
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The Datasets subdirectory contains the CPCRN datasets organized in raw data collected by study
Forms, as well as analysis datasets by study phases, and the sas program files used for generating
the analysis datasets:

“rawdata”: subdirectory containing 37 data files collected by the study Forms. The data
files with their associated forms are described in Tables 2.
Table 2: Study data files with their associated Forms
Data file
none
none
none
cmed_pckt
comp_sngl
none
none
def_pckt
none
none
none
epi_pckt
exam_pckt
excl_pckt
none
fgtm_pckt
fgtsc_pckt
fgtsc_pckt_02a
fgtsc_pckt_03a
fgtsc_pckt_05a
fgtsc_pckt_07a
fgtsc_pckt_09a
fgtsc_pckt_10a
fgtsc_pckt_12a
fgtsc_pckt_14a
none
ihc_pckt
incl_pckt
none
none
med_pckt
none
none
prior_pckt
none
rein_sngl
Version 1.0
Form
bcchk
bcrem
briefclinic
cmed
comp
cont
cpcrn_cohort_da
ta_entry_forms
def
dpcs
ecchk
ecrem
epi
exam
excl
extensiveclinic
fgtm
fgtsc
Description
Brief Clinic Contact Checklist
Brief Clinic Reminder
Brief Clinic Contact Checklist
Concomitant Medications
Patient Completion
Patient Contact Information
CPCRN Cohort Data Entry Forms
howto
ihc
incl
info
lab
med
miss
phone
prior
ref
rein
How To Complete Your Voiding Log
Interim Health Care
Inclusion Checklist
Uroflow Study - Patient Information
Lab Tracking Log
Medical History
Missing Contact
Telephone Log
Prior Treatments and Procedures
Patient Refusal Log
Patient Reinstatement
Deferral Checklist
Data Processing Cover Sheet
Extensive Clinic Contact Checklist
Extensive Clinic Reminder
Epidemiologic History
Physical Exam
Exclusion Checklist
Extensive Clinic Contact Checklist
Four Glass Test Microscopy
Four Glass Test Specimen Cultures
3
NIDDK Data Repository
10/2010
rus_03
rus_05
rus_07
rus_10
rus_form
rus_form_log
none
scr_pckt
none
semen_pckt
semen_pckt_07a
semen_pckt_09a
serum_pckt
swab_pckt
sxind_pckt
none
none
rus
Resource Utilization Survey
schk
scr
screening
semen
Screening Contact Checklist
Screening Confirmation
Screening Contact Checklist
Semen Sample
serum
swab
sxind
tchk
telephone
none
none
uro_pckt
void_pckt
with
track
trem
uro
void
with
Serum Sample
Urethral Swab
Symptom Index
Telephone Contact Checklist
Telephone Interview Form that combines the “Telephone
Contact Checklist” and “Symptom Index” Forms.
Status Tracking Log
Telephone Interview Reminder
Uroflow Study
Voiding Log
Patient Withdrawal






“Baseline”
o baseline062810: a summary analysis data file for all data collected at baseline.
“Longitudinal”
o longitude: a summary analysis data file for all data collected at longitudinal study
phase
“Case control”
o anal: a summary analysis data file for all data collected for the “CPC Control Group
Study”
“mkdata” – this subdirectory contains sas program files used to generate the analysis data
files from the raw data collected from the study Forms
o “Baseline”
o “Longitudinal”
o “Case control”
formats.sas7bcat – format file for the datasets
formats.cport – need description
3.2 SAS programs and results - this subdirectory contains sas program files used to generate the
analysis data files from the raw data collected from the study Forms

“Baseline”
o Demographic and clinical characteristics
 baseline1final.lst
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
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10/2010
 baseline1final.sas
 baseline1final.log
o Leukocyte and bacterial counts
 Baseline2final.lst
 Baseline2final.sas
 Baseline2final.log
“Longitudinal”
o longitudinal_final.lst
o longitudinal_final.sas
o longitudinal_final.log
“Case control”
o casecon_final.lst
o casecon_final.sas
o casecon_final.log
4. Data Set Integrity Check (DSIC)
The CPCRN Data Archive also contains a report of an examination of the repository for
completeness by statisticians and quality control specialists at the Repository. The published data
from the CPCRN study were compared to values recalculated from the CPCRN data in the NIDDK
repository to check for dataset completeness.
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