Case Record Form

Confidential

Case Record Form

Protocol Title

Protocol Number xxxxx / xx

This document must be returned to :

Address

GENERAL INSTRUCTIONS

Print clearly in CAPITAL LETTERS using a black ballpoint pen and press firmly so that all copies are legible. DO NOT print in shaded areas. Answer all questions on every page.

The plastic writing board in the back of the binder should be used to divide each set of pages before writing on them with a black ball point pen.

Important:Errors should be deleted with a single line and the alterations made as

close to the original as possible. All alterations must be printed

initialled and dated.

DATE

Use the following three letter abbreviations for month:

January = JAN

February = FEB

March= MAR

April= APR

May= MAY

June= JUN

July= JUL

August= AUG

September= SEP

October= OCT

November= NOV

December= DEC

Example 0 1 J A N 9 8= 1st January 1998

TIME

Unless specified otherwise, use the 24 hour clock: 00:00 to 23:59

Example1 4 2 5= 2:25 p.m.

Seed document for a study CRF, version 0.1

16/11/2011

Protocol / Centre Number / Patient Number / Patient Initials / Visit 1 (Day 0)
xxxxxx/xx / / / /

VISIT 1 - DAY 0

CHECKLIST

• INCLUSION/EXCLUSION CRITERIA
• DEMOGRAPHY, MEDICAL HISTORY AND PHYSICAL EXAMINATION
• PROMPT FOR
• PARASITOLOGY (BLOOD SLIDE)
• PCR
• HAEMATOLOGY DATA
• BIOCHEMISTRY DATA
• PRIOR MEDICATION HISTORY

Seed document for a study CRF, version 1.1

16/11/2011

Protocol / Centre Number / Patient Number / Patient Initials / Visit 1 (Day 0)
xxxxxx/xx / / / /

Page 1

Eligibility Checklist

Does the patient meet the following eligibility criteria?

Please answer the following questions by ticking the appropriate box.

Inclusion Criteria

If any of the following questions are answered ‘No’, the patient is not eligible

for the study Yes No

1. Presentation to the Outpatient Department of the hospital with probable
uncomplicated clinical malaria.

2. Age between 12 and 120 months (inclusive).

3. Pure (on microscopic grounds) P falciparum parasitaemia 2,000 to 100,000 l-1

4. Written or witnessed oral consent has been obtained from the parent or legal

guardian.

5. Parent or legal guardian is willing to allow the child to comply with the

protocol and particularly to provide venous and thumb prick samples.



If any boxes are ticked ‘No’ then the patient cannot be entered.Exclude

Patient

Page 2

Protocol / Centre Number / Patient Number / Patient Initials / Visit 2 ( Day 1 )
Xxxx/xx / / / /

Eligibility Checklist

Does the patient meet the following eligibility criteria?
Please answer the following questions by ticking the appropriate box.

Exclusion Criteria

Yes No

1. Any feature of severe malaria (Warrell et al 1990), including a haemoglobin

concentration of less than 6.5 g% or a parasitaemia greater than 100,000 l-1

(or estimated, on a thin film, to be greater than 10% of counted erythrocytes

parasitised).

2. A history of convulsions during the present illness.

3. General condition requiring hospital admission.

4. Evidence of a concomitant infection at the time of presentation (including rashes

other than scabies, red ear drums and abnormal respiratory system examination).

5. Any other underlying disease(s) that compromise the diagnosis and the

evaluation of the response to the study medication.

6. History of allergy to sulphonamides or dapsone.

7. Treatment within the last week with Fansidar, Metakelfin, mefloquine,

amodiaquine, halofantrine, quinine (full course), atovaquone-proguanil,

fansimef, artemisinins or co-artemether.

8. Visible jaundice.

9. Use of an investigational drug within 30 days or 5 half-lives whichever is the

longer.

10. A known

 

If any boxes are ticked ‘Yes’ then the patient cannot be entered. Exclude

Patient

Date of informed consent

day month year

I have assessed the patient and checked the inclusion/exclusion criteria and the patient is eligible for the study.

Investigator’s Signature...... Date ......

Protocol / Centre Number / Patient Number / Patient Initials / Visit 1 (Day 0)
xxxxx/xx / / / /

Page 3

Protocol / Centre Number / Patient Number / Patient Initials / Visit 1 (Day 0)
xxxx/xxx / / / /

Demography and Medical History

Date of Birth / / Sex Male Female
Does the patient have any significant medical history? Yes
No
If YES, please record as Diagnosis :
1.______
2.______
3.______
4.______/ Please tick ONLY
if Ongoing
Ongoing
Ongoing
Ongoing
Ongoing

Physical Examination and Symptom Assessment

Temperature . oC Method Axillary Oral Rectal ( tick one)
please use the same method throughout the study
Weight . kg.
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching Chills / Rigors Jaundice Others SPECIFY ______

CONCOMITANT MEDICATION

Please ask the following question: “Is your child taking any medication?”
Yes No
NOTE:
If YES please record details in Prior and Concomitant Medication section at the back of the Case Report Form

Page 4

Laboratory Evaluations

Has a blood sample been obtained for haematology and
biochemistry evaluation? Yes No
Has a blood sample been obtained for parasitology evaluation? Yes No
Has a filter paper been prepared for P.C.R.? Yes No
Results must be recorded in the Laboratory and Parasitology sections at the back
of Case Record Form.

Study Medication

Please note the time of the administering the study medication :
Was the dose vomited within 30 mins? No Yes If YESthen redose:
If redosed :
Was the re- dose vomited within 30 mins? No Yes If YESthen please
WITHDRAW the patient

PLEASE NOW ARRANGE FOR THE PATIENT TO BE SEEN TOMORROW

TO RECEIVE THEIR NEXT DOSE

VISIT 2 – DAY 1

CHECKLIST

• PROMPT FOR
• ADVERSE EVENTS
• CONCOMITANT MEDICATIONS
• ADMINISTER STUDY MEDICATION

NOTE

If this is the last visit that the patient attended please complete the Study Conclusion form at the back of the Case Report Form

Protocol / Centre Number / Patient Number / Patient Initials / Visit 2 (Day 1)
xxxx/xx / / / /

Page 5

SYMPTOM ASSESSMENT

Temperature .oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

ADVERSE EXPERIENCES

Please ask the following question: “Has your child appeared or felt different in any way since the last assessment?”
Yes No
NOTE:
Only tick YES for any new adverse experience or if there is a change in intensity or cessation of an ongoing adverse experience, as reported in Medical History on page 3.
If YES please record results in the Adverse Experience section at the back of the Case Report Form

CONCOMITANT MEDICATION

Please ask the following question: “Have there been any changes in your child’s medication since the last assessment?”
Yes No
NOTE:
Only tick YES for any new medication taken since Visit 1 or a cessation or change in dose of any current medication.
If YES please record results in Prior and Concomitant Medication section at the back of the Case Report Form

STUDY MEDICATION

Please note the time of the administering the study medication .
Was the dose vomited within 30 mins? NO YES If YES then redose:
If redosed :
Was the re- dose vomited within 30 mins? NO YES If YES then please
WITHDRAW the patient.

VISIT 3 – DAY 2

CHECKLIST

• PROMPT FOR
• ADVERSE EVENTS
• CONCOMITANT MEDICATIONS
• ADMINISTER STUDY MEDICATION

NOTE

If this is the last visit that the patient attended please complete the Study Conclusion form at the back of the Case Report Form

Protocol / Centre Number / Patient Number / Patient Initials / Visit 3 (Day 2)
xxxxx/xxx / / / /

Page 6

SYMPTOM ASSESSMENT

Temperature . oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

ADVERSE EXPERIENCES

Please ask the following question: “Has your child appeared or felt different in any way since the last assessment?”
Yes No
NOTE:
Only tick YES for any new adverse experience or if there is a change in intensity or cessation of an ongoing adverse experience.
If YES please record results in the Adverse Experience section at the back of the Case Report Form

CONCOMITANT MEDICATION

Please ask the patient the following question “Have there been any changes in your child’s medication since the last assessment?”
Yes No
NOTE:
Only tick YES for any new medication taken since Visit 2 or a cessation or change in dose of any current medication.
If YES please record results in Prior and Concomitant Medication section at the back of the Case Report Form

STUDY MEDICATION

Please note the time of the administering the study medication .
Was the dose vomited within 30 mins? NO YES If YES then redose:
If redosed :
Was the re- dose vomited within 30 mins? NO YES If YES then please
WITHDRAW the patient.

VISIT 4 – DAY 3

CHECKLIST

• PHYSICAL EXAMINATION

• PROMPT FOR
• PARASITOLOGY (BLOOD SLIDE)
• PCR
• HAEMOGLOBIN AND/OR HAEMATOCRIT OR METHAEMOGLOBIN
• BIOCHEMISTRY
• ADVERSE EVENTS
• CONCOMITANT MEDICATIONS

NOTE

If this is the last visit that the patient attended please complete the Study Conclusion form at the back of the Case Report Form

Protocol / Centre Number / Patient Number / Patient Initials / Visit 4 (Day 3)
xxxxx/xxx / / / /

Page 7

SYMPTOM ASSESSMENT

Temperature . oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

LABORATORY EVALUATION

Has a blood sample been obtained
for haematology and biochemistry evaluation? Yes No
Has a blood sample been obtained for parasitology evaluation? Yes No
Has a filter paper been prepared for P.C.R.? Yes No
Results must be recorded in the Laboratory and Parasitology sections at the back
of Case Record Form.

ADVERSE EXPERIENCES

Please ask the following question: “Has your child appeared or felt different in any way since the last assessment?”
Yes No
NOTE:
Only tick YES for any new adverse experience or if there is a change in intensity or cessation of an ongoing adverse experience.
If YES please record results in the Adverse Experience section at the back of the Case Report Form

CONCOMITANT MEDICATION

Please ask the patient the following question “Have there been any changes in your child’s medication since the last assessment?”
Yes No
NOTE:
Only tick YES for any new medication taken since Visit 3 or a cessation or change in dose of any current medication.
If YES please record results in Prior and Concomitant Medication section at the back of the Case Report Form

VISIT 5 – DAY 7

CHECKLIST

• PHYSICAL EXAMINATION
• PROMPT FOR
• PARASITOLOGY (BLOOD SLIDE)
• PCR (Suitably equipped centres only)
• HAEMATOLOGY*
• BIOCHEMISTRY*
• ADVERSE EVENTS
• CONCOMITANT MEDICATIONS

NOTE

* If there were abnormalities noted from the blood results on day 3 a repeat
sample may be required for analysis.

If this is the last visit that the patient attended please complete the Study Conclusion form at the back of the Case Report Form

Protocol / Centre Number / Patient Number / Patient Initials / Visit 5 (Day 7)
xxxxx/xx / / / /

Page 8

SYMPTOM ASSESSMENT

Temperature . oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

LABORATORY EVALUATION

Has a blood sample been obtained
for haematology and biochemistry evaluation? Yes No
Has a blood sample been obtained for parasitology evaluation? Yes No
Has a filter paper been prepared for P.C.R.? Yes No
Results must be recorded in the Laboratory and Parasitology sections at the back
of Case Record Form.

ADVERSE EXPERIENCES

Please ask the following question: “Has your child appeared or felt different in any way since the last assessment?”
Yes No
NOTE:
Only tick YES for any new adverse experience or if there is a change in intensity or cessation of an ongoing adverse experience.
If YES please record results in the Adverse Experience section at the back of the Case Report Form

CONCOMITANT MEDICATION

Please ask the patient the following question “Have there been any changes in your child’s medication since the last assessment?”
Yes No
NOTE:
Only tick YES for any new medication taken since Visit 4 or a cessation or change in dose of any current medication.
If YES please record results in Prior and Concomitant Medication section at the back of the Case Report Form

END OF STUDY – DAY 14

• PHYSICAL EXAMINATION
• PROMPT FOR
• PARASITOLOGY (BLOOD SLIDE)
• PCR (Suitably equipped centres only)
• HAEMATOLOGY *
• BIOCHEMISTRY *
• ADVERSE EVENTS
• CONCOMITANT MEDICATIONS

NOTES

If this is the last visit that the patient attended please complete the Study Conclusion form at the back of the Case Report Form

* If there were abnormalities noted from the blood results on day 3 a repeat
sample may be required for analysis.

Protocol / Centre Number / Patient Number / Patient Initials / Visit 6 (Day 14)
xxxxx/xx / / / /

Page 9

SYMPTOM ASSESSMENT

Temperature . oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

LABORATORY EVALUATION

Has a blood sample been obtained
for haematology and biochemistry evaluation? Yes No
Has a blood sample been obtained for parasitology evaluation? Yes No
Has a filter paper been prepared for P.C.R.? Yes No
Results must be recorded in the Laboratory and Parasitology sections at the back
of Case Record Form.

ADVERSE EXPERIENCES

Please ask the following question: “Has your child appeared or felt different in any way since the last assessment?”
Yes No
NOTE:
Only tick YES for any new adverse experience or if there is a change in intensity or cessation of an ongoing adverse experience.
If YES please record results in the Adverse Experience section at the back of the Case Report Form

CONCOMITANT MEDICATION

Please ask the patient the following question “Have there been any changes in your child’s medication since the last assessment?”
Yes No
NOTE:
Only tick YES for any new medication taken since Visit 5 or a cessation or change in dose of any current medication.
If YES please record results in Prior and Concomitant Medication section at the back of the Case Report Form

EXTRA VISITS

• PHYSICAL EXAMINATION
• PROMPT FOR
• PARASITOLOGY (BLOOD SLIDE)
• PCR
• HAEMATOLOGY *
• BIOCHEMISTRY *
• ADVERSE EVENTS
• CONCOMITANT MEDICATIONS

If this is the last visit that the patient attended please complete the Study Conclusion form at the back of the Case Report Form

* If there were abnormalities noted from the blood results on day 3 a repeat
sample may be required for analysis.

Protocol / Centre Number / Patient Number / Patient Initials / Extra Visit
xxxxx/xx / / / /

Page 10

SYMPTOM ASSESSMENT

Temperature . oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

LABORATORY EVALUATION

Has a blood sample been obtained
for haematology and biochemistry evaluation? Yes No
Has a blood sample been obtained for parasitology evaluation? Yes No
Has a filter paper been prepared for P.C.R.? Yes No
Results must be recorded in the Laboratory and Parasitology sections at the back
of Case Record Form.

ADVERSE EXPERIENCES

Please ask the following question: “Has your child appeared or felt different in any way since the last assessment?”
Yes No
NOTE:
Only tick YES for any new adverse experience or if there is a change in intensity or cessation of an ongoing adverse experience.
If YES please record results in the Adverse Experience section at the back of the Case Report Form

CONCOMITANT MEDICATION

Please ask the patient the following question “Have there been any changes in your child’s medication since the last assessment?”
Yes No
NOTE:
Only tick YES for any new medication taken since the last Visit or a cessation or change in dose of any current medication.
If YES please record results in Prior and Concomitant Medication section at the back of the Case Report Form

Page 11

SYMPTOM ASSESSMENT

Temperature . oC Method Axillary Oral Rectal (tick one)
please use the same method throughout the study
Please record presence of any of the following symptoms;
Headache Dizziness Nausea Vomiting Diarrhoea Abdominal Pain Itching
Chills / Rigors Jaundice Others SPECIFY ______

LABORATORY EVALUATION

Has a blood sample been obtained
for haematology and biochemistry evaluation? Yes No
Has a blood sample been obtained for parasitology evaluation? Yes No
Has a filter paper been prepared for P.C.R.? Yes No
Results must be recorded in the Laboratory and Parasitology sections at the back
of Case Record Form.

ADVERSE EXPERIENCES