Project application form
SIBDC-Project Nr:
SWISSIBD cohort study
Title:
Short title (optional):
Authors:
Administrative Information
Corresponding investigator:
Responsible investigator:
Coordinating centre:
Study sites:
Study starting date:
Study duration:
Budget information:

Amount allocated by SIBDCS (nested projects only):

Other grants allocated (donator’s name and amount):
Date of first submission:
If this is a revised protocol: Date of resubmission:
____
I confirm that I have read the Guidelines for Project Submission and that the project fulfils all
criteria.
(Any issue that might interfere with the guidelines should be discussed in a cover letter)
_____ I confirm that all co-authors have seen the current version of the project and agreed with the
submission of the current version of the protocol
Document1
page 1/17
Project application form
If the current version is a revision of a previously submitted proposal:
Give a point-by-point reply to the comments received from the Scientific Board and highlight
the resulting relevant changes in this proposal with yellow.
Point-by-point reply to the comments from the Scientific Board:
-
Submit the project to: sibdcs-submission@chuv.ch
page 2/17
Project application form
Summary (structured, max 300 words)
Background
[Present state of knowledge in the area of the proposed research with key references]
Study Hypotheses
[Description of the hypothesis which this project proposes to test]
Study Aims and Objectives
[Major aim and objectives of the project in relation to state of knowledge. Scientific and practical
significance of the proposed research]
Own Research in the Field
[Relevant experience and list of publications of the corresponding author. Relevant background
information on the other investigators]
Methodology
1.1
Patients
[Precise list of inclusion and exclusion criteria of patients that should be included in the present study.
Preliminary enquiry should be made to the Datacentre in order to evaluate total number of eligible
patients. Give the results and details of sample size calculation]
1.2
Study design
[Description of the overall study design. Description of the processes for data collection, and the
rationale behind this method. Include a flow chart of the project]
1.3
Data Analysis
[Description of the complete list of variables to be used to answer the question, with arguments behind
the choice. List and definition of the principal and secondary outcomes. Description of the statistical
methods to be employed]
Time Frame
[Time-frame for the project (including explicit and detailed research tasks to be performed within the
credit and the duration of the project)]
Submit the project to: sibdcs-submission@chuv.ch
page 3/17
Project application form
Status of Ethical Approval
[Mention of the ethics approval or amendment this research protocol refers to. Ethical committee to
contact (if applicable)]
Study Budget (must be detailed)
[Indicate infrastructure and manpower already available for the study. Indicate what funds you expect
to obtain from other sources (industry, SNFS, foundations, etc...). The budget should include
appropriate details as well as external funded expenses. For personnel, the requested position(s) and
duration should be justified by a description of the tasks. The budget of the study should take into
account only costs not already covered by the SIBDCS core research projects and infrastructure.
Specify the following costs: personnel, laboratory tests, specimen retrieval, reimbursement to the
participating centers, special tasks requested from the Datacenter, diverse.]
Other Information
[Interim analysis (if applicable). How you imagine disseminating your results (publication in scientific
journal, thesis, internal report, conference, etc.). A proposal for authorship should be part of each
submitted project. National or international collaborations (if applicable).DTA or MTA (if applicable)]
References
APPENDIXES:
- Variables lists and definitions (enrolment & follow-up physician questionnaires)
- Check list for requested biosamples
Submit the project to: sibdcs-submission@chuv.ch
page 4/17
Project application form
Requests for Biosamples from the SIBDCS Biobank - Check list
Please include the following documents / information with your request for biosamples ()
Title/ID of the research project: …………………………………………………….
Copy of the approved research proposal

Members of the SIBDCS consortium: Copy of the acceptance letter for the
project by the Head of the Scientific Committee

External requests (Non-SIBDCS Members): Copy of the signed Material
Transfer Agreement (MTA)

 Maximum number of serum samples requested:
N = ..................
Minimum amount (in microliter) of serum required per sample ........

 Maximum number of plasma samples requested:
N = ..................
Minimum amount (in microliter) of plasma required per sample ........

 Maximum number of DNA samples requested:
N = ..................
Minimum concentration of DNA required (determined by nanodrop®) .....ng/µl
Minimum total amount of DNA required per sample .......... ng

 Maximum number of biopsies (in RNA later) requested:
N = ..................
(precise localisation and specifications according to information provided to the
datacenter in Lausanne)

Contact for scientific questions) .........................................................................
..............................................................................................................................

Shipping address ..............................................................................................
Submit the project to: sibdcs-submission@chuv.ch
page 5/17
Project application form
SIBDC-Project Nr:
VARIABLES AND DEFINITIONS – ENROLLEMENT AND FOLLOW-UP PHYSICIAN QUESTIONNAIRE
Variable
Definition
Description (coding)
Date of visit
Date at which the follow-up questionnaire is started to be filled in
Date in format DD.MM.YYYY
Date of last report
Date at which the last physician questionnaire was filled in, provided that it
has been registered and received at the cohort datacenter
Date in format DD.MM.YYYY
Cohort Number (patient
identification control)
Unique number of identification of a patient included into the cohort
Number in format XX.XXX.XXXX
Gender
Gender of the patient
Categorical:
- Male
- Female
Weight
Weight of the patient at the date of follow-up visit
Continuous variable (kg)
Date of birth
Date of birth of the patient
Date in format DD.MM.YYYY
Treating physician(s)
Name of the physician(s) – GI or GP – who usually follows the patient for
his/her IBD
Text (CAPITAL letters)
Cohort physician
Name of the physician who is responsible for the follow-up visit and
examination
Text (CAPITAL letters)
Study nurse / research
assistant
Name of the collaborator who is responsible for filling in the report, if
applicable
Text (CAPITAL letters)
Current diagnosis
Diagnosis of the patient at the date of follow-up visit
Categorical:
- Crohn’s disease
- Ulcerative colitis
- Indeterminate colitis
Pregnancy
Pregnancy status of women and number of weeks of pregnancy at the date
of the follow-up visit, if applicable
Categorical:
- No
- Yes
Conception
Conception activity of women/men in the period since last report to the
cohort
Categorical:
- No
- Yes
- Unknown
Current smoking status
Smoking status at the date of follow-up visit
Categorical:
- Non-smoker
- Stopped since last report to the cohort
- Current smoker
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Project application form
Variable
Current severity of disease:
Crohn’s disease (CDAI)
SIBDC-Project Nr:
Definition
Instantaneous measure of disease severity at the date of follow-up visit
Description (coding)
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Project application form
SIBDC-Project Nr:
Variable
Current severity of disease:
Ulcerative colitis /
Indeterminate colitis (MTWAI)
Definition
Instantaneous measure of disease severity at the date of follow-up visit
Description (coding)
Clinical course
Monthly evolution of the disease activity since the date of the last report to
the cohort till to the date of the current follow-up visit
Categorical:
 Active
o Active without specifications
o Active with specifications: severe, moderate, mild
 Not Active
o Medically-induced
o Surgically-induced
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Project application form
SIBDC-Project Nr:
Variable
Past AND current therapies
Definition
List of all therapies, PREVIOUS AND CURRENT, targeted for IBD care,
taken by the patient since the last report to the cohort
Drug administration
Mode of drug administration
Start date
Date of therapy start
Dosage
Dosage of the drug therapy
Drug and flare
Flare management and use of the drug therapy
Description (coding)
Categorical:
- None
- Oral 5-ASA (Asacol®, Mesazine®, Pentasa®, Salofalk®, Dipentum®)
- Topical 5-ASA (Asacol®, Salofalk®)
- Sulfasalazine (Salazopyrin®)
- Metronidazole (Flagyl®, Metrolag®, Arilin®)
- Ciprofloxacin (Ciproxine®, Cip eco®, Ciprine®, Principrox®)
- Other antibiotics, please specify
- Cyclosporine (Sandimum®, Ciclosol®)
- Tacrolimus (Prograf®)
- Azathioprine (Imurek®, Azarek®)
- 6-Mercaptopurine (Puri-Nethol®)
- Infliximab (Remicade®)
- Adalimumab (Humira®)
- Certolizumab pegol (Cimzia®)
- Methotrexate (Methotrexate®)
- Budesonide (Budenofalk®, Entocort®)
- Topical steroids (Entocort®, Enema®, Colifoam®, Budenofalk®)
- Ursodeoxycholic acid (Ursofalk®, De-ursi®)
- Bisphosphonates (Aredia®, Fosamax®, Actonel®, Zometa®, Bonviva®)
- Cholestyramine (Quantalan®, Ipocol®)
- Systemic steroids (Prednisone®, Calcort®)
- Mutaflor®
- VSL#3®
Categorical:
- Foam
- Supp.
- Enema.
- i.v.
- p.o.
- s.c.
Categorical:
- Date in format MM.YY
- Start date not found
Categorical:
- d (daily)
- w (weekly)
- 8w (every 8 weeks) for Infliximab
- 2ow (every other week) for Adalimumab
- 4w (every 4 weeks) for Certolizumab pegol
- Shortening dose interval (yes, no)
- On tapering scheduled (yes, no)
- Targeted to flare management
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Project application form
SIBDC-Project Nr:
Variable
Definition
Description (coding)
Conception and pregnancy
Drug therapy during conception (female and male) and pregnancy
- Given during conception (male) or pregnancy
Stop date
Date of therapy stop
- Date in format MM.YY
- Stop date not found
Drug response
Response to the past drug therapy
Categorical:
- Prior successful
- Failure
- Unknown
Reasons for failure
Reasons for drug failure
Categorical:
- Breakthrough / loss of response
- Primary non response (never effective)
- Side effects / intolerance
Reasons for drug discontinuation
Categorical:
- Patient wish
- Conception / pregnancy
- No longer needed
- Other, specify
Other reasons for
discontinuation
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Project application form
Variable
Therapy adverse events of
stopped therapies
SIBDC-Project Nr:
Definition
Adverse events related to drugs that were stopped since last report to the
cohort
Description (coding)
Categorical:
- None
- Abd. Pain / Diarrhea
- Abnormal taste
- Anaphylaxia
- Arthralgias
- Bowel obstruction
- Cataracts / Glaucoma
- Cough / Pneumonitis
- Cushingoid features
- Diabetes / Glucose intoler.
- Exanthema
- Gastrointestinal intolerance, please specify
- Headache
- Hepatitis
- Hirsutism
- Hypersensitivity reaction, please specify
- Injection site pain
- Leucopenia/Thrombopenia/Lymphopenia
- Liver cirrhosis / Fibrosis
- Lupus like syndroma
- Myalgias
- Nausea / Abd. Pain
- Nausea / Diarrhea
- Neuropathy
- Nephritis
- Oedema
- Opportunistic infections
- Osteonecrosis
- Osteopenia / Osteoporosis
- Pancreatitis (Lipase)
- Pseudomemb. Colitis
- Psoriasis-like Exanthema / skin effection
- Psychosis / Depression
- Pyrexia
- Renal hypertension
- Seizure / Coma
- Sinusitis / Upper resp tr inf
- Stomatitis / Mucositis
- TBC
- Tendinitis /Tenosynovitis
- Tremor
- Wheeze / Cough / Dyspnea
- Other adverse events, please specify
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Project application form
SIBDC-Project Nr:
Variable
Supplementation therapy
Definition
Supplementation therapies taken by the patient since the last report to the
cohort
Laboratory values
Most recent core and optional laboratory values obtained for the patient
within +/- 3 months
Date of blood sample
Date of blood sample withdrawal
Time of blood sample
Time of blood sample withdrawal
Description (coding)
Categorical:
- None
- Magnesium
- Calcium
- Folate
- Oral iron
- i.v. iron
- Lactase
- Potassium
- Fish oil / Omega 3
- Multivitamins
- Vitamin D
- Vitamin E
- Vit. B12
- Pancreatic enzyme
- Enteral nutrition
- Parenteral nutrition
- Other, please specify
- Bioflorin® (Probiotic)
- Perenterol® (Probiotic)
- Other probiotics, please specify
Categorical:
- Leucocytes
- Hb
- Ht
- CRP
- ESR (VS / BSG)
- Fecal calprotection
- Ferritine
- Vit. B12
- Folate
- Alk. Phosp.
- Albumin
- ALAT / SGPT
- ASAT / SOPT
- Date in format DD.MM.YYYY
- At date of follow-up
- Time in format HH.MM
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Project application form
Variable
SIBDC-Project Nr:
Definition
Description (coding)
Factors related to the last
flare
Specific risk factors for the last reported flare
Categorical:
- None
- NSAIDs
- Antibiotics, specify
- GI tract infections
- Other infection
- Treatment decrease / discontinuation
- Other medication
Date of flare
Start date of the LAST reported flare
Management
Management of the LAST reported flare
- Date in format MM.YYYY
- No new flare since last report to the cohort
- Hospitalization (number, total days)
- Ambulatory
- Surgery
- Drug therapy
Last disease location
assessment
Method used to newly assess the disease location since the last report to
the cohort
Categorical:
- no new evaluation since last report to the cohort
- unknown
- New evaluation:
- Endoscopic studies
- Surgery
- Radiological studies
Date of disease location
assessment
Date at which the examination was performed to assess the disease
location
Date in format MM.YYYY
Endoscopic activity
Endoscopic activity of unhealthy bowel segments
Histological findings
Histological findings made during endoscopic or surgical assessment
Categorical:
- Active
- Inactive
- Unknown
- No biopsy performed
- Histological findings: yes, no, unknown
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Project application form
Variable
Intestinal resection surgeries
Surgery for fistula and
abscesses
Other abdominal surgery
SIBDC-Project Nr:
Definition
Type of performed resection surgeries performed since the date of the last
follow-up report
Type of surgeries involving fistula and abscesses performed since the date
of the last follow-up report
Type of other abdominal surgeries performed since the date of the last
follow-up report
Description (coding)
Categorical:
- None
- Ileal resection (synonymous (syn.): resection ileo-ileal, resection term ileum)
- Other small bowel resection (syn.: jejunal or jejunum resection, resection
jejunum 110cm, or resection of medul diverticulum)
- Ileo-caecal resection (syn.: ileo-caecal recaecectomy, ileo-ascendant
anastomosis)
- Right colectomy (syn.: ileo-transverse anastomosis, ileo-trans anastomosis,
right
hemicolectomy, right partial colectomy)
- Left colectomy (syn.: left hemicolectomy)
- Ileostomy (syn.: Terminal ileostomy)
 Closure of ileostomy
- Colostomy (syn.: sigmoidostomy, transversostomy)
 Closure of colostomy (syn.: colorectal anastomosis)
- Sigmoid resection (syn. anterior colon resection, Sigma resection, Sigma
segment resection, Sigmoïd part resection, or sigmoïdectomy)
- Protectomy (syn.: low anterior resection, rectum resection, total proctectomy)
- Stricturoplasty
- Subtotal colectomy (syn.: ileo-rectal anastomosis, ileo-sigmoid anastomosis)
 ileostomy
 ileo-rectal anastomosis
- Total proctocolectomyn (syn.: total colectomy, total coloproctectomy)
 ileostomy
 ileo-anal pouch
Categorical:
- Fistula plug
- Perianal abscess drainage
- Fistulectomy/Fistulotomy
- Seton drainage
- Intra-abdominal abscess drainage
- Fibrin glue instillation
- Mucosal sliding flap
Categorical:
- Adhesiolysis
- Appendectomy
- Cholecystectomy
- Other abdominal surgeries
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Project application form
Variable
SIBDC-Project Nr:
Definition
Description (coding)
Exams
All new exams performed since the date of the last report to the cohort
Categorical:
- None
- Colonoscopy
- Gastrocopy
- CT scan
- MRI scan
- Ultrasonography
- Wireless capsule
- Other new exams
Clinical outcomes
All outcomes originated by a new exam for each CONCERNED month
since the date of the last report to the cohort
Extraintestinal manifestations
(EIM)
Indicate all extraintestinal manifestations reported since the date of the last
report to the cohort
Categorical:
- No outcomes
- Mucosal healing
- Active disease
- Inactive scars
- Stenosis
- Abscess
- Fistula
- Other outcomes
Categorical:
- None
- Peripheral arthritis/arthralgia
- Uveitis/Iritis
- Pyoderma gangrenosum
- Erythema nodosum
- Aphtous oral ulcers/ stomatitis
- Ankylosing spondilitis (Bechterew)
- Sacroilitis
- Primary sclerosing cholangitis
- Other EIM
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Project application form
SIBDC-Project Nr:
Variable
Type of complications
Definition
Indicate any complications reported for each CONCERNED month since
the date of the last report to the cohort
Description (coding)
Fistulas, abscesses, fissure
The location of origin of the complication (fistulas, abscesses and/or fissures), the
code number of the complication
Status of fistula, abscesses,
and/or fissures
Status and time point(s) that the complication (fistula, abscesses and/or fissure)
occurred since the date of the last report
Stenosis
Presence and location of stenosis occurred since the date of the last report
Categorical:
- None
- Low perianal fistula (B-E)
- High perianal fistula (A)
- Perineal fistula
- Rectovaginal fistula
- Entero-enteral fistula
- Entero-vesical fistula
- Entero-cutaneous fistula
- Other fistula (specify)
- Perianal abscess
- Abdominal abscess
- Other abscess (specify)
- Anal fissure
Categorical:
- Surgical therapy
- Steady state
- New/Reopening
- Improvement
- Closure
Categorical:
- None
- Oesophagus (A)
- Duodenum/Jejunum (B)
- Ileum (C)
- Large bowel (D-H)
- Rectum (I)
- Anus (J)
- Anastomosis
Categorical:
- None
- Colorectal cancer
- Colon dysplasia
- Intestinal lymphoma
- Osteoponia/osteoporosis
- Anemia (not due to drug AE)
- Deep venous thrombosis
- Pulmonary embolism
- Nephrolitiasis
- Gallstone
- Malabsorption syndrome
- Massive hemorrhage
- Perforation/peritonitis
- Pouchitis
- Other complication
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Project application form
SIBDC-Project Nr:
Variable
Definition
Stenosis status
Status of stenosis (complication) and time point(s) it occurred since the
date of the last report
Length of stenosis
Length of the current stenosis
Description (coding)
Categorical:
- Operation
- Dilation
- No intervention
- Symptoms resolved (yes, no)
Length of stenosis:
- ≤ 7cm,
- >7 cm
- unknown
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