INFORMED CONSENT FORM

S.no

Item Question Is the subject willing to 1 sign informed consent

Item Response

Control Type

Standard item included

Yes No

Radio control Radio control

Yes Yes

Date of Informed consent

Date and time field

Yes

Item Response Design Update guidelines

Yes Yes Nested under yes 2012-2013

Yes

INCLUSION EXCLUSION CRITERIA

sno

Item Question

Item Response

Standard item Item Response Control Type included Update Design guidelines

Did subject met all Inclusion/exclusion 1 criteria? Yes No Inclusion 1 2 3 4 5 6 7 Exclusion 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Radio control Yes Radio control Yes

Yes Yes Nested under No

Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box Check box

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

DATE OF VISIT FORM

S.No

Item Question

Item Response Control Type

Standard Item item Response included Update

Design guidelines

1 Date of visit

Date and time field Yes

Yes

2012-2013

S.No Item Question 1 Date of birth 2 Age Units

Item Response

Control Type Date and time field Numeric field

Design guidelines 1925-1995 XX Nested under age

Years Months Days

Radio control Radio control Radio control Radio control Radio control Radio control Radio control Radio control Radio control Radio control Text field

3 Gender

Male Female Nor Male or Female

4 Ethnicity

Indian Hispanic Non-Hispanic Others.

If others please specify 5 Race African caucassian Asian Others If others please specify

Nested under others A255

Radio control Radio control Radio control Radio control Text field Nested under others A255

MEDICAL HISTORY FORM

Sno

Item Question

Item Response Control Type

Standard item included

Item Response Update

Did subject had any 1 medical history? Yes No 2 Medical history term 3 Start date 4 Ongoing Yes No End date

Radio control Radio control Text field Date and time field Radio control Radio control Date and time field

Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes

Design guidelines

A255 1925-2013

Nested under no 1925-2013

VITAL SIGNS FORM Item Standard item Response included Update Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes No No Yes Yes Yes Yes

S.No

Item Question Actual date of vital 1 signs 2 Blood Pressure

Item Response

Control Type Date and Time field

Systolic Diastolic

Numeric field Numeric field Text field Numeric box

Units 3 Pulse Units 4 Temperature Units

mmHg

Beats per minute

Text field Numeric decimal

Degree centigrade Fahrenheit

Radio control Radio control Numeric decimal

5 Weight Units kilograms pounds 6 Height Units Inches Centimeters Meters 7 Respiratory rate Units 8 oxygen saturation Units Milligrams per litre Breaths per minute

Radio control Radio control Numeric decimal Radio control Radio control Radio control Numeric decimal Text field Numeric decimal Text field

Design guidelines 2012-2013 XXX XXX

XX

XXX.X Nested under temperature

XXX.X Nested under weight

Nested under height X.XX XXX.X X.X XX.X Nested under Respiratory rate XX.X Nested under Oxygen saturation

ADVERSE EVENT FORM

S.No

Item Question 1 Adverse event term Adverse event 2 start date

Item Response

Control Type Text box Date and time field

Standard item included Yes

Item Response Update Yes

Yes

Yes

3 Ongoing ?

Yes No

Radio button Radio button Date and time field

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

End date Outcome of Adverse 4 event Resolved

Radio button

Recovering Radio button Recovering with sequel Radio button Fatal Not recoverd Relationship with the 5 drug Radio button Radio button

Possibly related Radio button Not related probably Definitely Radio button Radio button Radio button

Action Taken by study 6 drug

Drug Withdrawn Radio button Drug interuptted Radio button No Action taken Radio button Dose increased Radio button

7 Severity

Mild Moderate

Radio button Radio button

Severe 8 CTC grade I II III IV V

Radio button Radio button Radio button Radio button Radio button Radio button

Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes

9 Is AE an SAE?

Yes No Fatal

Radio button Radio button Check box

Yes Yes Yes Yes

Yes Yes Yes Yes

Life threatening Check box Prolong hospitalization Disability Congenital anomoly An Important medical event

Check box Check box

Yes Yes

Yes Yes

Check box

Yes

Yes

Check box

Yes

Yes

Design Guildines A255

2012-2013

Nested Under No 2012-2013

Nested under yes

CONCOMITANT MEDICATION FORM

Sno Item Question 1 Medication name 2 Indication

Item Response

Control Type Text field

Standard item Item Response included Update Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Adverse event Medical history Others

Radio control Radio control Radio control Text field

If Others please specify 3 Start date 4 Ongoing Yes No End date 5 Frequency 6 Medication category 7 Reason 8 Dose Units 9 Route of adminstation Mg g

Date and time field Yes Radio control Radio control Yes Yes

Date and time field Yes Text field Text field Text field Numeric decimal field Radio control Radio control Text field Yes Yes Yes Yes Yes Yes Yes

ION FORM

Design guidelines A255

A255 Nested under others 1925-2013

Nested under no 1925-2013 A255 A255 A255 XXX.XX Nested under dose A255

DATE OF DISPOSITION FORM

Sno

Item Question

Item Response

Control Type

Standard item included

1 Date of disposition

Date and time field Yes

2 Reason for disposition

Adverse event

Radio control

Yes

Protocol violation Pregnancy Withdrawl of subject

Radio control Radio control Radio control

Yes Yes Yes Yes Yes

Subject withdrawl consent Radio control Others Radio control

If Others please specify

Text field

Yes

TION FORM

Item Response Update Design guidelines

Yes

2012-2013

Yes

Yes Yes Yes Yes Yes Nested under others A255

Yes