Castor Form Exchange | CRB standard pages

1.1

Is informed consent obtained?

1.1.1

Date of informed consent

Only shown if field 1.1 is equal to Yes

1.1.2

Is consent given for substudy X?

Only shown if field 1.1 is equal to Yes

1.1.3

Is consent given for future research?

Only shown if field 1.1 is equal to Yes

1.1.4

Is consent given for storage of bodily material for 15 years?

Only shown if field 1.1 is equal to Yes

Inclusion criteria

2.1

Inclusion criterium A

2.2

Inclusion criterium B

2.3

Inclusion criterium C

2.4

Inclusion criterium D

2.5

Inclusion criterium E

Exclusion criteria

2.6

Exclusion criterium A

2.7

Exclusion criterium B

2.8

Exclusion criterium C

2.9

Exclusion criterium D

2.10

Exclusion criterium E

Inclusion

2.11

Does the patient fullfill all inclusion criteria and none of the exclusion criteria?

2.11.1

Date of inclusion

Only shown if field 2.11 is equal to Yes

2.11.2

Check date inclusion

Only shown if field 2.11 is equal to Yes

3.1

Age at inclusion

3.2

Gender

3.2.1

Child bearing potential

Only shown if field 3.2 is equal to Female

3.2.1.1

Is a pregnacy test required?

Only shown if field 3.2.1 is equal to Yes

3.3

Race

3.4

Height

3.5

Does the patient smoke?

3.5.1

Enter the number of pack-years

Only shown if field 3.5 is not No, never smoked

3.6

Does the patient drink alcohol?

3.6.1

Enter the number of units per week

Only shown if field 3.6 is equal to Yes

3.7

Baseline medical conditions

3.7.1

List of all baseline medical conditions

Only shown if field 3.7 is equal to Yes

4.1

Date of vital signs

4.2

Weight

4.3

BMI

4.4

WHO score / ECOG Performance Status

4.5

Systolic bloodpressure

4.6

Diastolic bloodpressure

4.6.1

Check bloodpressure

Only shown if field 4.6 is not 'NA'

4.7

Pulse

4.8

Temperature

4.9

Physical examination done?

4.9.1

Findings physical examination

Only shown if field 4.9 is equal to Yes

4.9.1.1

Abnormal findings

Only shown if field 4.9.1 is equal to Abnormal

5.1

Pregnancy test

Only shown if field 3.2.1.1 is equal to Yes

5.2

Lab sample taken?

5.2.1

Date lab sample taken

Only shown if field 5.2 is equal to Yes

Hematology

Only shown if field 5.2 is equal to Yes

5.2.3

BSE

Only shown if field 5.2 is equal to Yes

5.2.4

C-reactive protein

Only shown if field 5.2 is equal to Yes

5.2.5

Hemoglobin

Only shown if field 5.2 is equal to Yes

5.2.6

Hematocrit

Only shown if field 5.2 is equal to Yes

5.2.7

Thrombocytes

Only shown if field 5.2 is equal to Yes

5.2.8

Leukocytes

Only shown if field 5.2 is equal to Yes

Differentiation

Only shown if field 5.2 is equal to Yes

5.2.10

Eosinophils

Only shown if field 5.2 is equal to Yes

5.2.11

Basophils

Only shown if field 5.2 is equal to Yes

5.2.12

Neutrophils

Only shown if field 5.2 is equal to Yes

5.2.13

Lymphocytes

Only shown if field 5.2 is equal to Yes

5.2.14

Monocytes

Only shown if field 5.2 is equal to Yes

Hemostasis

Only shown if field 5.2 is equal to Yes

5.2.16

PT

Only shown if field 5.2 is equal to Yes

5.2.17

APTT

Only shown if field 5.2 is equal to Yes

Kidney function

Only shown if field 5.2 is equal to Yes

5.2.19

Sodium

Only shown if field 5.2 is equal to Yes

5.2.20

Potassium

Only shown if field 5.2 is equal to Yes

5.2.21

Calcium

Only shown if field 5.2 is equal to Yes

5.2.22

Magnesium

Only shown if field 5.2 is equal to Yes

5.2.23

Phosphate

Only shown if field 5.2 is equal to Yes

5.2.24

Glucose

Only shown if field 5.2 is equal to Yes

5.2.25

Creatinine

Only shown if field 5.2 is equal to Yes

5.2.26

eGFR (MDRD)

Only shown if field 5.2 is equal to Yes

5.2.27

Urea

Only shown if field 5.2 is equal to Yes

Liver function

Only shown if field 5.2 is equal to Yes

5.2.29

Bilirubin

Only shown if field 5.2 is equal to Yes

5.2.30

AF

Only shown if field 5.2 is equal to Yes

5.2.31

Y-GT

Only shown if field 5.2 is equal to Yes

5.2.32

ASAT

Only shown if field 5.2 is equal to Yes

5.2.33

ALAT

Only shown if field 5.2 is equal to Yes

5.2.34

LD

Only shown if field 5.2 is equal to Yes

5.2.35

Amylase

Only shown if field 5.2 is equal to Yes

5.2.36

Lipase

Only shown if field 5.2 is equal to Yes

Blood

Only shown if field 5.2 is equal to Yes

5.2.38

TSH

Only shown if field 5.2 is equal to Yes

5.2.39

Free-T4

Only shown if field 5.2 is equal to Yes

5.2.40

CEA

Only shown if field 5.2 is equal to Yes

6.1

Did the patient complete the whole study?

6.1.1

Date of study completion

Only shown if field 6.1 is equal to Yes

6.1.2

Check end of study date

Only shown if field 6.1 is equal to Yes

6.1.3

Date of early trial discontinuation

Only shown if field 6.1 is equal to No

6.1.3.1

Check date of early trial discontinuation

Only shown if field 6.1.3 is not 'NA'

6.1.4

Reason of early trial discontinuation

Only shown if field 6.1 is equal to No

6.1.4.1

Cause of death

Only shown if field 6.1.4 is equal to Withdrawal of consent

6.1.4.2

Why was this decision made?

Only shown if field 6.1.4 is equal to Decision of the investigator

7.1

(Serious) Adverse Events

7.1.1

List of all (Serious) Adverse Events

Only shown if field 7.1 is equal to Yes

8.1

Did the patient use concomitant medication during the study?

8.1.1

List of all concomitant medication

Only shown if field 8.1 is equal to Yes

9.1

Was there a protocol deviation?

9.1.1

List all protocol deviations

Only shown if field 9.1 is equal to Yes

10.1

Was study medication dispensed?

10.1.1

List of all study medication

Only shown if field 10.1 is equal to Yes

11.1

Response evaluation according to RECIST

11.1.1

List of all response evaluations

Only shown if field 11.1 is equal to Yes

1.1

Medical condition

1.2

Ongoing

1.3

Severity

1.4

Medication taken

If medication taken is answered with YES, then please enter the medication to the concomitant medication page

Only shown if field 1.4 is equal to Yes

1.1

Event name

1.2

Start date

1.3

Check start date event

1.4

Stop date

1.5

Check stop date event

1.6

Severity

1.7

Related to study intervention?

1.8

Action taken (in case of study medication)

1.9

Outcome

1.10

SAE?

If SAE is answered with YES, then please report the SAE in ToetsingOnline

Only shown if field 1.10 is equal to Yes

1.1

Drug name

1.2

Indication

1.3

Total daily dose (incl. unit)

1.1

Date the deviation occured

1.2

Check date protocol deviation

1.3

Type of protocol deviation

1.4

Describe the reason why the deviation occurred

1.5

Should action be taken?

1.5.1

Type of action

Only shown if field 1.5 is equal to Yes

1.5.1.1

Describe the action taken

Only shown if field 1.5.1 is equal to Other

1.6

Does this deviation increase the risk for the subject?

1.6.1

Describe the increased risk for the subject

Only shown if field 1.6 is equal to Yes

1.7

Does this deviation effect the reliability of the data?

1.7.1

Describe the effect on the reliability of the data

Only shown if field 1.7 is equal to Yes

1.1

Name

1.2

Dose

1.3

Dose change?

1.3.1

Reason dose change

Only shown if field 1.3 is equal to Yes

1.4

Start date

1.5

Check start date

1.6

Stop date

1.7

Check stop date

1.1

Date of scan

1.2

Total of target lesions

1.3

Response target lesions

1.4

New non-target lesions?

1.5

Response non-target lesions

1.6

Overall response

YesNo

1: Yes

0: No

Gender

0: Female

1: Male

Race

1: White

2: Asian

3: Black or African American

4: American Indian or Alaska Native

5: Native Hawaiian or Other Pacific Islander

Smoking

2: Yes, current smoker

1: No, former smoker

0: No, never smoked

AE: severity

1: Mild

2: Moderate

3: Severe

WHO score

0: 0

1: 1

2: 2

3: 3

4: 4

5: 5

NormalAbnormal

1: Normal

2: Abnormal

PositiveNegative

1: Positive

0: Negative

Reason Early Trial Discontinuation

0: Death

1: Lost to Follow Up

2: Withdrawal of consent

3: (Serious) Adverse Event

4: Decision of the investigator

5: Early termination of the whole study

AE: related to study intervention

1: Certainly related

2: Possibly related

3: Not related

AE: action taken

0: None

1: Stopped permanently

2: Stopped temporarily

3: Dose reduced

4: Dose increased

AE: outcome

1: Recovered

2: Is recovering

3: Not recovered

4: Recovered with sequela

5: Patient died

6: Unknown

Protocol deviation: type of deviation

1: In- and exclusion criteria

2: Studyprocedure

3: (Study)medication

Protocol deviation: type of action

1: Subject can participate/continue in the study

2: Subject is not eligible and can not partcipate in the study

3: Subject should be excluded from the study

4: Other

Reason dose change study medication

1: According to protocol

2: (Serious) Adverse Event

3: Decision of the investigator

4: Decision of the patient

RECIST

1: Complete Response

2: Partial Response

3: Stable Disease

4: Progressive Disease