PLEASE TICK ~√ THE APPROPRIATE BOXES AND COMPLETE … · OSAC Case Report Form v1.0 (01 May 2013) Page 4 of 11 8. Blood pressure: (range 80 Systolic: –180mmHg) If values higher

OSAC (Oral Steroids for Acute Cough) Trial CASE REPORT FORM

Section 1 (YELLOW CRF): Face-to-Face Patient Eligibility Check To be completed for: all patients willing to be screened for eligibility to participate in the OSAC trial (NB: all questions to be completed)

To be completed by: Responsible Clinician (NB: on paper or online)

OSAC Case Report Form v1.0 (01 May 2013) Page 1 of 11

Today’s Date:

D D M M Y Y Y Y

OSAC Screening ID:

[affix SID label]

Patient ID Number:

[affix PID label]

OSAC Site ID:

OSAC Clinician ID:

PLEASE TICK (√) THE APPROPRIATE BOXES AND COMPLETE SECTION 1 IN FULL

Is the patient willing to be screened for eligibility to participate in the OSAC trial, and for data to be stored anonymously if they are not eligible?

□ Yes □ No

1.1 INCLUSION CRITERIA

Please exclude the patient if the answer is ‘NO’ to any of the following (apart from question 3, for which only one screening symptom is necessary for eligibility):

1. Aged 18 years or over □ Yes □ No

2. Consulting for an acute (≤ 28 days) cough as the main presenting symptom □ Yes □ No

3. In the past 24 hours, the patient has had at least one of the symptoms listed below (a-d), localizing to the lower respiratory tract and suggestive of an acute respiratory tract infection (RTI):

a. Phlegm (sputum) □ Yes □ No

b. Chest pain □ Yes □ No

c. Shortness of breath □ Yes □ No

d. Wheeze □ Yes □ No

4. Patient and practice have sufficient time for consent and randomisation into the trial by the end of today? □ Yes □ No

5. Patient able and willing to give informed consent? □ Yes □ No

6. Patient able and willing to complete the daily symptom diary? □ Yes □ No

7. Patient able and willing to receive weekly telephone calls from the trial team? □ Yes □ No

1.2 EXCLUSION CRITERIA

Please exclude the patient if the answer is ‘YES’ to any of the following:

1. Known lung cancer or chronic lung disease (e.g. COPD, bronchiectasis or cystic fibrosis)? □ Yes □ No

2. Has an ‘active’ diagnosis of asthma (‘active’ meaning has received any asthma medication in the past 5 years)

□ Yes □ No

3. Does the patient’s RTI warrant same day hospital admission or immediate antibiotics? (NB: use of delayed prescription does not preclude OSAC trial participation)

If yes, please choose the appropriate options (A-C) below and tick all relevant boxes:

□ Yes □ No

According to NICE guidelines, the patient warrants immediate antibiotic treatment by virtue of ONE OR MORE of the following:

A. Is clinically very unwell or has symptoms and signs suggestive of pneumonia, e.g. tachypnoea (>20bpm), unilateral chest signs or consolidation, or hypoxia (oxygen saturation <94%); or other systemic infection, e.g. suspected bacteraemia

□

B. Is at high risk of complications, including patients with chronic heart, chronic lung (e.g. COPD, bronchiectasis or CF), chronic renal, chronic liver or neuromuscular disease or immunosuppression; or with complications from previous episodes of lower respiratory tract infection e.g. hospital admission for pneumonia

□

C. AGED OVER 65 years with at least TWO of the following criteria, or AGED OVER 80 years with at least ONE of the following criteria:

i. Unplanned hospitalisation within the previous year;

ii. Type 1 or Type 2 diabetes;

iii. History of cardiac failure

□

4. Requires an antibiotic today to treat another infection unrelated to their acute cough, e.g. a co-existing cellulitis

□ Yes □ No

5. Recently (≤1 month) used inhaled corticosteroids □ Yes □ No

OSAC (Oral Steroids for Acute Cough) Trial CASE REPORT FORM

Section 1 (YELLOW CRF): Face-to-Face Patient Eligibility Check To be completed for: all patients willing to be screened for eligibility to participate in the OSAC trial (NB: all questions to be completed)

To be completed by: Responsible Clinician (NB: on paper or online)


6. Recently (≤1 month) used short (≤2 weeks) course systemic corticosteroids □ Yes □ No

7. Currently using, or has previously (≤12 months) used, systemic steroids for a cumulative period >2 weeks, i.e. “long-term” use

□ Yes □ No

8. Known to be pregnant, is trying to conceive or is at risk of pregnancy (e.g. unwilling to take a reliable form of contraception) in the next month?

□ Yes □ No

9. Currently breast-feeding? □ Yes □ No

10. This is not the patient’s usual practice, i.e. patient is visiting or is not intending to stay with the practice for the 3 month trial follow up period

□ Yes □ No

11. Previously entered in the OSAC trial □ Yes □ No

12. Has been involved in another medicinal trial within the last 90 days or any other clinical research study within the last 30 days?

□ Yes □ No

13. Is unable to give informed consent or complete the trial paperwork (including the symptom diary) through mental incapacity, e.g. major current psychiatric illness, learning difficulties and dementia

□ Yes □ No

14. Known immune-deficiency (e.g. chemotherapy causing immunosuppression, asplenia or splenic dysfunction, advanced cancer or HIV infection)

□ Yes □ No

15. Has any of the following (A – P) known contra-indications or cautions to oral steroids □ Yes □ No

Current OR previous history of:

A. Peptic ulcer disease E. Osteoporosis

B. Previous TB F. Glaucoma

C. NO previous chickenpox AND known recent (≤28 days) history of close personal contact with chickenpox OR herpes zoster

G. Suspected ocular herpes simplex

H. Cushing’s disease

I. Epilepsy

D. Known allergy to prednisolone or other OSAC trial tablet ingredients (potato starch, lactose monohydrate, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate), galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

J. Severe affective disorders, e.g. manic depression,

previous steroid psychosis

K. Previous steroid myopathy

L. Intention to use a live vaccine in the next 3 months

(NB: assess live vaccine status by checking with BNF)

Current history only:

M. Uncontrolled diabetes (HbA1C > 8%) O. Taking other interacting medication, e.g. phenytoin and anti-coagulants (NB: check patient’s medications for interactions as specified below “FOR ALL PATIENTS”)

N. Uncontrolled hypertension (NB: Responsible Clinician’s judgement)

P. ANY OTHER BNF listed contra-indication or caution

FOR ALL PATIENTS: please check the British National Formulary (BNF) and use the patient’s electronic medical record to check for medicine interactions, by prescribing prednisolone (quantity = “*0* as per OSAC trial”)

16. Were any significant interactions with the patient’s existing medication identified? □ Yes □ No

17. Is unable to swallow tablets □ Yes □ No

Paperwork Management

If the patient is eligible for OSAC trial entry, return the completed Section 1 form to recruitment folder Part 3 and continue to Section 2. Enter Section 1 on the OSAC clinical database WITHIN 24 HOURS.

If the patient is not eligible for trial entry, please do not proceed with recruitment, update the clinical database WITHIN 24 HOURS and file Section 1 in the OSAC Site File.

If the patient DOES NOT WISH TO CONTINUE with trial participation AND CONSENTS TO USE OF DATA COLLECTED THUS FAR, update the OSAC clinical database WITHIN 24 HOURS and place Section 1 in the OSAC Site File.

If the patient WITHDRAWS VERBAL CONSENT TO USE DATA COLLECTED THUS FAR, please note on the Screening Log and shred Section 1 at Recruitment Site.

Please complete the Screening Log for ALL patients approached for trial participation.

OSAC (Oral Steroids for Acute Cough) Trial Section 2 (GREEN CRF): Clinical Examination, Observations and Diagnosis CASE REPORT FORM To be completed for: all patients confirmed eligible in Section 1 (NB: all

questions to be completed) To be completed by: Responsible Clinician (NB: on paper or online)


Today’s Date:

D D M M Y Y Y Y

OSAC Screening ID:

[affix SID label]

Patient ID Number: [affix PID label]

OSAC Clinician ID:

2.1 CLINICAL EXAMINATION AND OBSERVATIONS (MUST BE COMPLETED IN FULL FOR ELIGIBLE PATIENTS)

Please examine all of the following in ALL patients.

1. General condition: □ Normal □ Abnormal

If abnormal, please recheck that the patient is eligible for OSAC and tick all that apply:

□ Pallor □ Flushed □ Dehydrated

□ Other, please specify:

2. Throat: □ Normal □ Abnormal

If abnormal, please recheck that the patient is eligible for OSAC and tick one box that best applies:

□ Red or Inflamed □ Quinsy □ Discharge or Pus


3. Temperature: . oC (range 35.0 – 42.0)

4. Which type of thermometer was used?

□ Infrared ear □ Infrared skin □ Axillary □ Oral

5. Chest: □ Normal □ Abnormal

If abnormal, please recheck that the patient is eligible for OSAC and tick all the signs that apply, indicating whether

unilateral OR bilateral:

Unilateral OR Bilateral

Bronchial breathing*

Wheeze / rhonchi

Crackles / crepitations

Decreased air entry

Other, please specify:

□

□

□

□

□

□

□

□

□

□

Please tick all that apply:

□ Recession (Intercostal / subcostal / supra-clavicular)* □ Prolonged expiration

□ Other chest sign,

please specify:

*If bronchial breathing or recession, please consider the presence of pneumonia (in which case the patient is ineligible for OSAC)

6. Respiratory rate normal?

If yes, please enter rate:

□ Yes □ No

(range 12 - 20bpm)

7. O2 saturation: % (range 94 – 100%)

OSAC (Oral Steroids for Acute Cough) Trial Section 2 (GREEN CRF): Clinical Examination, Observations and Diagnosis CASE REPORT FORM To be completed for: all patients confirmed eligible in Section 1 (NB: all

questions to be completed) To be completed by: Responsible Clinician (NB: on paper or online)


8. Blood pressure: Systolic: (range 80 – 180mmHg) If values higher than the upper limits indicated (i.e. respiratory rate >20bpm; O2 sats <94%; pulse rate >120bpm; or if pulse is irregular) please reassess patient in case their illness warrants same day antibiotic or hospital treatment, and/or the patient should be excluded as too unwell to participate in the OSAC trial.

Diastolic: (range 50 – 100mmHg)

9. Pulse rate: (range 50 – 120bpm)

10. Pulse rhythm: □ Regular □ Irregular

11. What is your working diagnosis? Please tick one box that best describes your diagnostic label:

□ Lower respiratory tract Infection (LRTI) □ Chest infection □ Acute bronchitis


12. Do you plan on giving this patient a delayed antibiotic script? (please tick one box)

□ Yes, for the acute cough □ No NB: patients requiring immediate antibiotics should be excluded from the OSAC trial

If yes, which antibiotic? (please tick one box)

□ Amoxicillin □ Erythromycin □ Clarithromycin □ Doxycycline □ Co-amoxiclav (Augmentin)


Dosage (mg): Frequency per day:

Duration (days):

How long is the patient advised to delay starting antibiotics (days)?

13. Did you prescribe any medication (apart from the OSAC trial medication and a delayed antibiotic)?

□ Yes □ No

If yes, enter the name(s) of the medication(s) below:

a)

b)

c)

d)

14. Where was the patient seen by the Responsible Clinician? (please tick one box)

□ GP practice □ Patient’s home □ Nursing home or residential institution


If the patient is still eligible on completion of Section 2, AUTHORISE THE OSAC TRIAL PRESCRIPTION by completing all relevant sections, place in the recruitment folder and update the patient’s medical notes to reflect issue of the trial prescription.

Enter Section 2 on the OSAC clinical database WITHIN 24 HOURS. Return ALL completed paperwork to recruitment folder Part 3 and hand to the Recruiting Clinician.

If the patient is not eligible for trial entry, please do not proceed with recruitment, update the OSAC clinical database WITHIN 24 HOURS and file Section 2 in the OSAC Site File.

If the patient DOES NOT WISH TO CONTINUE with trial participation AND CONSENTS TO USE OF DATA COLLECTED THUS FAR, update the OSAC clinical database WITHIN 24 HOURS and place Sections 1 & 2 in the OSAC Site File.

If the patient WITHDRAWS VERBAL CONSENT TO USE DATA COLLECTED THUS FAR, please note on the Screening Log and shred Sections 1 & 2 at Recruitment Site.

Please complete the Screening Log for ALL patients approached for trial participation.

OSAC (Oral Steroids for Acute Cough) Trial Section 3 (PINK CRF): Participant Registration CASE REPORT FORM To be completed for: all patients confirmed eligible in Sections 1 and 2, for

whom the Responsible Clinician has authorised the OSAC trial prescription and who have completed a written consent form.

To be completed by: Recruiting Clinician (3.1, blue section) and Patient (3.2-3.8) (NB: ALL on paper only).


3.1 RECRUITING CLINICIAN TO COMPLETE:

Today’s Date:

D D M M Y Y Y Y

Patient ID Number:

[affix PID label]

OSAC Clinician ID:

GOOD CLINICAL PRACTICE CHECKS

1. Have CRF sections 1 and 2 been fully and correctly completed? □ Yes

2. Has the patient read and completed the OSAC trial consent form?

NB: if the consent form is not completed, do not proceed.

□ Yes

PATIENT TO COMPLETE:

3.2 PARTICIPANT’S DETAILS

First name: Surname:

Date of birth: / / Gender: □ Female □ Male

NHS number: Post code:

3.3 PARTICIPANT’S PREFERENCES: WEEKLY TELEPHONE CONTACTS NB: Your contact details will only be used by the research team for the period of your involvement in the trial and will not be passed on to anyone else.

1. I would like the research team to use the following number as my first preference for the weekly follow-up telephone calls:

Number: This is my: □ Work □ Home □ Mobile

2. I would like the research team to use the following number as my second preference for the weekly follow-up telephone calls:

Number: This is my: □ Work □ Home □ Mobile

3. I would prefer the research team to contact me by telephone at the following weekday time(s):

□ 09:00–12:00 □ 13:00–17:00 □ 17:00–20:00 □ Anytime □ After___________ am/pm

3.4 PARTICIPANT’S PREFERENCES: COMPLETING THE SYMPTOM DIARY AND DAILY CONTACTS NB: Your contact details will only be used by the research team for the period of your involvement in the trial, and will not be passed on to anyone else.

1. I would prefer to complete the symptom diary: □ On-line □ On paper

2. I would like to receive twice daily (morning and evening) reminders to remind me to record my peak flow measurements and complete the symptom diary:

□ Yes □ No

3. I would like to receive these reminders by automated e-mail or by text: □ E-mail □ Text

My e-mail address:

My mobile number for text reminders (if different from a mobile number provided above):

4. I would like to receive my daily automated e-mail or text reminders at the following times (tick one box only):

□ Mornings (07:00-10:00) □ Evenings (17:00-19:00) □ Morning & evening


Fax this page only (Questions 3.1-3.4) to the Bristol OSAC Trial Centre secure fax no: 0117 928 7341, before the end of the same working day.

D D M M Y Y Y Y





3.5 OCCUPATION AND EMPLOYMENT

1. Which of the following best describes you? (please tick one box only)

□ Employed (full or part-time, including self-employed) □ Unemployed

□ Unable to work due to long-term illness / disability □ In full-time education

□ Retired from paid work □ Not working for other reasons

2. Please describe your current or most recent paid employment. If you have more than one job, tell us about your main job. If

you’ve never been in paid work; please go to section 3.6 below.

3.6 ETHNICITY

1. Please describe your ethnic group (tick one box only):

a) White: □ British □ Irish □ Any other White background

b) Black or Black British: □ African □ Caribbean □ Any other Black background

c) Mixed: □ White and Black

Caribbean

□ White and Black

African

□ White and Asian □ Any other Mixed

background

d) Asian or Asian British: □ Indian □ Pakistani □ Bangladeshi □ Any other Asian

background

e) Chinese or Other Ethnic Group:

□ Chinese □ Any other (please tick the box and detail below)

f) Prefer not to answer: □ Please tick here

3.7 EXPOSURE TO SMOKE

1. What are your previous or current smoking habits?

□ Never □ Past □ Current

2. If past or current smoker:

How many per day, normally? For how many years?

3. Does anyone else in your household smoke? □ Yes □ No





3.8 YOUR QUALITY OF LIFE (EQ-5D-5L) NB: The questions on this and the next page can only be completed on paper and cannot be entered on the OSAC online clinical database.

Under each heading, please tick the ONE box that best describes your health TODAY:

MOBILITY

I have no problems in walking about

I have slight problems in walking about

I have moderate problems in walking about

I have severe problems in walking about

I am unable to walk about

SELF-CARE

I have no problems washing or dressing myself

I have slight problems washing or dressing myself

I have moderate problems washing or dressing myself

I have severe problems washing or dressing myself

I am unable to wash or dress myself

USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)

I have no problems doing my usual activities

I have slight problems doing my usual activities

I have moderate problems doing my usual activities

I have severe problems doing my usual activities

I am unable to do my usual activities

PAIN / DISCOMFORT

I have no pain or discomfort

I have slight pain or discomfort

I have moderate pain or discomfort

I have severe pain or discomfort

I have extreme pain or discomfort

ANXIETY / DEPRESSION

I am not anxious or depressed

I am slightly anxious or depressed

I am moderately anxious or depressed

I am severely anxious or depressed

I am extremely anxious or depressed





We would like to know how good or bad your health is TODAY.

This scale is numbered from 0 to 100.

100 means the best health you can imagine.

0 means the worst health you can imagine.

Mark an X on the scale to indicate how your health is TODAY.

Now, please write the number you marked on the scale in the box below.

YOUR HEALTH TODAY =

*UK (English) v.2 © 2009 EuroQol Group. EQ-5D™ is a trade mark of the EuroQol Group)


Return the whole of Section 3 and the signed consent form to the Bristol Trial Centre in the pre-paid envelope supplied (in the recruitment folder) as soon as possible.

If the patient DOES NOT WISH TO CONTINUE WITH TRIAL PARTICIPATION, please complete the OSAC withdrawal form and handle Sections 1, 2 & 3 forms accordingly.

OSAC (Oral Steroids for Acute Cough) Trial Section 4 (BLUE CRF): Symptoms, Signs and Medical History

CASE REPORT FORM To be completed for: all patients confirmed eligible in Sections 1 and 2, for whom the Responsible Clinician has authorised the OSAC trial prescription and who have completed a written consent form.

To be completed by: Recruiting Clinician (NB: on paper or online)


Today’s Date:

D D M M Y Y Y Y

Patient ID Number:

[affix PID label)

OSAC Clinician ID:

4.1 CLINICAL OBSERVATIONS (MUST BE COMPLETED FOR ALL PATIENTS)

NB: Recruiting Clinician to check all clinical observations in Section 2 have been completed before proceeding. Please perform any observations if left blank by Responsible Clinician.

Please measure and record the patient’s height and weight on the day of recruitment, UNLESS*:

1. Weight: kg *If the patient has been weighed in the last month, the most recent weight can be taken from the electronic record.

2. Height (record to 2 decimal

places): . m *If the patient’s height has been measured in the past 5 years, the

most recent height can be taken from the electronic record. 3. Patient’s predicted peak

expiratory flow rate: This information can be taken from the patient’s electronic record

(enter their weight and height first) or from http://www.peakflow.com/top_nav/normal_values/PEFNorms.html

4. Has the patient been shown how to use the peak flow meter? □ Yes □ No

5. Patient’s actual peak expiratory flow rate

(best of 3 attempts):

Please use the EU Scale Adult Standard Mini Wright Peak Flow Meter provided in the Patient Pack only. Do not use any other type of peak flow meter for the OSAC trial.

6. Assessment of patient’s peak expiratory flow measurement technique: □ Very good □ Adequate □ Poor

If the patient’s actual peak flow rate is <75% of their predicted peak flow rate, the Responsible Clinician should be informed.

4.2 CURRENT SYMPTOMS: PATIENT’S PERSPECTIVE (RECRUITING CLINICIAN TO ASK PATIENT)

1. For how many days (including today) have you been unwell with the cough? (enter number between 1-28)

2. Compared with yesterday, do you feel the same, better or worse? (tick one box only)

□ Same □ Better □ Worse

3. Please rate your overall impression of your illness in the past 24 hours, on a scale of 0-10: (circle one number)

Completely Extremely well unwell

4. Symptoms Has the symptom been present at any time? If yes, is this within the last 24 hours?

Yes No Yes No

a) Phlegm (sputum) □ □ □ □

If yes to phlegm, what colour? □ Clear □ White □ Yellow □ Green □ Bloodstained □ Other

b) Shortness of breath □ □ □ □

c) Wheeze □ □ □ □

d) Blocked / runny nose □ □ □ □

e) Fever □ □ □ □

f) Chest or shoulder pain □ □ □ □

g) Muscle aches □ □ □ □

h) Headache □ □ □ □

i) Disturbed sleep □ □ □ □

2 5 8 9 10 0

6 7 0 1 3 4

http://www.peakflow.com/top_nav/normal_values/PEFNorms





Symptoms cont. Has the symptom been present at any time? If yes, is this within the last 24 hours?

Yes No Yes No

j) Feeling generally unwell □ □ □ □

k) Unable to do normal activities of daily living

□ □ □ □

l) Confusion / disorientation □ □ □ □

m) Diarrhoea □ □ □ □

Any other symptoms at any time?

If yes, please describe:

□ Yes □ No

Symptom 1:

Is this within the last 24 hours? □ Yes □ No

Symptom 2:


Symptom 3:


4.3 PAST MEDICAL AND FAMILY HISTORY (NB: Validated questions - wording of questions must be used exactly as written)

Thinking back to the 12 months before your current illness started:

1. Have you had wheezing or whistling in your chest at any time in the last 12 months? □ Yes □ No

2. Have you been woken up at night by an attack of shortness of breath at any time in the last 12 months? □ Yes □ No

3. Have you been woken up at night by an attack of coughing at any time in the last 12 months? □ Yes □ No

4. Have you woken up with a feeling of tightness in your chest at any time in the last 12 months? □ Yes □ No

5. Have you had an attack of shortness of breath that came on following strenuous activity at any time? □ Yes □ No

6. Have you had an attack of shortness of breath that came on during the day when you were at rest at any time?

□ Yes □ No

7. If the answer to any of the above is “Yes”, do your symptoms occur less frequently or not at all on days away from work and on vacations?

□ Yes □ No

8. Does the weather affect your cough? □ Yes □ No □ No cough

9. Do you ever cough up phlegm (sputum) from your chest when you do not have a cold? □ Yes □ No

10. Do you usually cough up phlegm (sputum) from your chest first thing in the morning? □ Yes □ No

11. How frequently do you wheeze? □ Occasionally or more often □ Never

12. Do you or another member of your family have any history of eczema? □ Yes □ No □ Don’t know

If yes, please tick as many as apply: □ You □ Parent □ Sibling

13. Do you or another member of your family have any history of hay fever? □ Yes □ No □ Don’t know

If yes, please tick as many as apply: □ You □ Parent □ Sibling

14. Do you or another member of your family have any history of asthma? □ Yes □ No □ Don’t know

If yes, please tick as many as apply: □ You* □ Parent □ Sibling

* If the patient has taken medication for asthma within the past 5 years, they should be excluded from the OSAC trial.





4.4 MEDICATIONS, INCLUDING PRESCRIBED MEDICATIONS (PLEASE ASK PATIENT AND ALSO CHECK PATIENT’S MEDICAL RECORD)

1. Did you have an influenza vaccination in the last 12 months? □ Yes □ No

2. Have you treated this cough with any over-the-counter medications? □ Yes □ No

If yes, please enter details:

3. Have you taken, in the past 24 hours, any of the following prescribed medication? Tick one box for each question.

(NB: these are not exclusion criteria)

a) Inhaled bronchodilators, e.g. salbutamol □ Yes □ No

b) Oral non-steroidal anti-inflammatories □ Yes □ No

c) Topical non-steroidal anti-inflammatories □ Yes □ No

d) Antihistamines, e.g. Piriton □ Yes □ No

e) Benzodiazepines / antidepressants □ Yes □ No

f) Anti-hypertensives □ Yes □ No

g) Aspirin □ Yes □ No

h) Oral beta-blockers, e.g. atenolol, bisoprolol, propranolol □ Yes □ No

i) Beta-blocking glaucoma eye drops □ Yes □ No

j) Oral agents for diabetes □ Yes □ No

k) Other prescribed medication □ Yes □ No

If yes, please enter details:


When complete, place Section 4 in the recruitment folder. Ensure Sections 1, 2 and 4 are entered on the OSAC clinical database.

On satisfactory completion of recruitment processes, please place the recruitment folder (with all relevant paperwork) securely in a lockable storage location in line with Good Clinical Practice, Data Protection Act guidelines and MHRA requirements.

Return the completed recruitment folders in batches to the Bristol OSAC Trial Centre using the supplied Freepost address labels.

If at any stage the patient becomes ineligible to continue with trial participation or wishes to withdraw do not proceed with recruitment, and if applicable complete the WITHDRAWAL FORM.

Please ensure responsible personnel (as per delegation log) update the patient’s medical record to indicate participation in the OSAC trial.

Documents

PLEASE TICK ~√ THE APPROPRIATE BOXES AND COMPLETE … · OSAC Case Report Form v1.0 (01 May 2013) Page 4 of 11 8. Blood pressure: (range 80 Systolic: –180mmHg) If values higher