CRFS

CRFS

           FOR SCREENING VISIT

1)                   PATIENT  INFORMATION(DEMO)

2)                   MEDICAL HISTORY &

     CONCURRENT CONDITIONS                      

3)                   BIRTH CONTROL INFORMATION

4)                   CONCURRENT MEDICATIONS

5)                   LAB INFORMATION

6)                   COMMENTS

            BASE LINE VISIT

1)                   INFORMATION(VITAL SIGNS)

2)                   BIRTH CONTROL INFORMATION

3)                   LAB SAMPLES INFORMATION

4)                   ADVERSE EVENT INFORMATION

5)   NEW OR CHANGED CONCURRENT

     MEDICATION

6) COMMENTS

               SCHEDULE CRFS

1)                INFORAMTION(VITAL SIGNS)

2)                ADVERSE EVENTS INFORMATION

3)   NEW OR CHANGED CONCURRENT

     MEDICATION

4)  LAB SAMPLE TEST INFORMATION

5)  COMMENTS

UNSHEDULE CRFS

1)                INFORMATION(VITAL SIGNS)

2)                NEW OR CHANGED CONCURRENT

       MEDICATIONS

3) ADVERSE EVENT INFORMAION

SCREENING VISIT : In this visit, the investigator collects the information of all the patients like age, SBP, DBP ,HR  and others.

      BASELINE visit: In this visit, the patient is given study drug. In this visit also, all the above information to be collected.

Concurrent medications:

                        If the patients is using any other medicines (called concurrent medications), these are to be noted.

Data set names:

Demographic (or) DM: Center, Patid, SEGID (visit name)

These variables available in each and every dataset

LAB: all the information regarding SBP, DBP, HR and others are available.

CM: In this dataset, the concurrent medications are available with start date (CMSTDTC) and end date (CMENDTC).

AE: In this dataset, all the Adverse events are available with start date (AESTDTC) and end date (AEENDTC).

END: End of dosing information available

SD: All patients’ medication starting dates

       Are available (variable name Sdate)

CRF MODEL-1

SCREEN NO

SCREENING VISIT     PATIENT       INFORMATION

TIME(24hrs)

H

DATE

RANDOMIZATION     NO

D

D

M

M

Y

Y

CENTER     NO

DEMOGRAPHICS   DATE OF BIRTH

RACE ETHNICITY

ASIAN

BLACK

OTHER

NATIVE AMERICAN

D

D

M

M

Y

Y

SEX

MALE

FEMALE

INFORMED CONSENT  SIGNED    YES NO YES NO  ASIGNED SCREEN NUMBER? D D M M Y Y YES    DATE OF BIRTH           IF THE PATIENT TAKING       CONCOMITANT MEDICATION

VITAL SIGNS BLOOD PRESSURE BODY TEMPRETURE PLUSE RATE WEIGHT RESPIRATORY   RATE

mmHg degrees F beats/min lb breaths/min

CRF MODEL-2

SCREEN NO

SCREENING VISIT   MEDICAL HISTORY         &         CONCURRENT     CONDITIONS

TIME(24hrs)

H

S

DATE

RANDOMIZATION     NO

D

D

M

M

Y

Y

CENTER     NO

CODE  NO

DIAGNOSIS/OR PROCEDURE

ONSET DATE

RESLOVED ONGOING

01

M M D D Y Y

R O

02

M M D D Y Y

R O

CRF MODEL-3

SCREEN NO

SCREENING VISIT       PRIOR         &         CONCURRENT     MEDICATIONS

TIME(24hrs)

H

S

DATE

RANDOMIZATION     NO

D

D

M

M

Y

Y

CENTER     NO

UNIT CODES

FREQUENCY CODES

ROUTE CODES

1=mg        2=ml 3=tablets   4=capsules 5=units 6=drops 7=grams

1=QD  2=BID 3=TID 4=QID 5=PRN

1=oral 2=IV 3=IM 4=SC 5=topical

NO

MEDICATION

DOSE

STARTDATE

STOP DATE

INDICAT ION

SCREEN NO

LABORATORY     INFORMATION

TIME(24hrs)

H

H

M

M

S

S

S

DATE

RANDOMIZATION     NO

D

D

M

M

Y

Y

CENTER     NO

LAB SAMPLES  WERE LAB SAMPLES DRAWN?   COVANCE LAB ACCESSION      NUMBER  :    WAS A URINE SAMPLE TAKEN IF YES,DATE OF SAMPLE PREGNANCY TEST RESULTS PREGNANCY TEST CONDUCTED

YES NO D D M M Y Y