Study name/Acronym
Department
CLINICAL INVESTIGATION PLAN (CIP)
EN ISO 14155
Klinischer Prüfplan (MPG §3)
Name of the Investigation
Identifying number
Version / Date
Confidentiality Statement
The information contained in this document, especially unpublished data, is the property of the
sponsor of this clinical investigation…………………………………. (please adapt for your own study). It is
therefore provided to you in confidence as an investigator, potential investigator, or consultant, for
review by you, your staff, and an Independent Ethics Committee or Institutional Review Board. It is
understood that this information will not be disclosed to others without written authorization from
the …………………., except to the extent necessary to obtain informed consent from those persons to
whom the interventional devices may be administered.
Date
Version
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Study name/Acronym
Department
Device Name and
Manufacturer
CIP authors
Academic investigators
Document type
Medical Device CIP
Document status
Date
Number of pages
Date
Version
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Department
1.
SPONSOR, INVESTIGATOR, MONITOR AND SIGNATURES
Clinical investigator
(MPG § 3)
Prim.Univ.-Prof. Dr.AB, Department of………., Medical University of
Vienna, Austria
_________________
___________
Signature
Date
Sponsor/OEL
(MPG § 3)
Medical University of Vienna, Austria or company
_________________
Signature
Representative of CRO
(EN ISO 14155 )
Name: ………….
_________________
Signature
Statistician
___________
Date
Name: ……….
_________________
Signature
Date
___________
Date
Version
___________
Date
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2.
SYNOPSIS OF THE CLINICAL INVESTIGATION
Provided preferably on a separate page, it should summarize all the central elements of the CIP
(Clinical Investigation Plan), for example the rationale, objectives, methods, populations, time frame,
and expected outcomes. It should stand on its own, and not refer the reader to points in the project
description.
(example - please adapt to your study)
TITLE
ACRONYM
NAME OF DEVICE
please enter
(abbreviated title)
Dev1
DESCRIPTION OF THE
PROCEDURES
The …dev1…. an investigational device intended to ….. in individuals
suffering from ….. The device system is to be used only in accordance
with the approved Investigational Plan on subjects who have signed an
informed consent form. Device use is limited to the approved study
investigators.
OBJECTIVES
The CIP shall identify clearly the hypothesis and objectives, primary
and secondary, of the clinical investigation and the populations for
which the device is to be used in the investigation. These shall include
as appropriate the particular:
⇾ Claims and intended performance of the device that are
verified This may include implicit in the intended purpose of
the device as well as those made explicit in labeling,
instructions for use or promotional material. It should be
clearly stated wheter or not the determinations of the longterm effect are part of the objectives of the current clinical
investigation,
⇾ Risk and foreseeable adverse device effects that are be
assessed
⇾ Specific hypotheses to be accepted or rejected by statistical
data from the clinical investigation.
e.g. Primary Objective
(May include claims implicit in the intended purpose of the device as
well as those made explicit in labeling, instructions for use or
promotional material)

To demonstrate treatment efficacy of …. long-term dev1 (it should
be clearly stated whether or not the determination of long-term
effects are part of the objectives of the current clinical
investigation) ………in comparison to ……., as measured by a
………………
e.g. Secondary Objectives
 To assess safety and tolerability of dev1 in patients with……
 To asses effect of dev1 treatment on quality of live
 To assess differences in treatment efficacy in patients with and
without…………….
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TYPE OF THE INVESTIGATION Prospective, multicenter, randomized, parallel group, double-blind,
controlled,
PERIOD OF ENROLMENT
First patient 1Q
Last patient
1Q
Last patient 3Q
First visit
First visit
Last visit
CENTER(S)
X centers in X country.
/ COUNTRY(IES)
Austria
PATIENTS / GROUPS
XY patients in X groups
XY patients per group
Randomization ratio 1:1, stratification
INCLUSION CRITERIA
 .
 .
EXCLUSION CRITERIA

COMPARATIVE DEVICE
CONCOMITANT
MEDICATION/CONCOMITANT DEVICE
if applicable, please specify (e.g. allowed, not allowed)
EFFICACY ENDPOINTS
TOLERABILITY / SAFETY
ENDPOINTS
QUALITY OF LIFE
STATISTICAL METHODOLOGY 
Primary Endpoint
 Null and alternative hypotheses:
H0
H1:
Type-I and -II errors - power.
α
ß
Interim analysis
.
 Statistical methodology
.
 Sample size calculation.
.
 Main analysis set
 Other endpoints
STUDY EXTENSION
Date
.
Version
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3.
LIST OF ABBREVATIONS
Provide a list of abbreviations used in the Clincial investigation plan
Date
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Department
4.
TABLE OF CONTENTS
CLINICAL INVESTIGATION PLAN (CIP) ............................................................................................ 1
1. SPONSOR, INVESTIGATOR, MONITOR AND SIGNATURES ......................................................... 3
2. SYNOPSIS OF THE CLINICAL INVESTIGATION ........................................................................... 4
3. LIST OF ABBREVATIONS.......................................................................................................... 6
4. TABLE OF CONTENTS .............................................................................................................. 7
TABLE 1. VISIT AND ASSESSMENT SCHEDULE ................................................................................. 9
5. INTRODUCTION ................................................................................................................... 10
5.1
BACKGROUND INFORMATION ........................................................................................................... 10
5.2
RATIONALE OF THE CLINICAL INVESTIGATION....................................................................................... 10
6. OBJECTIVES OF THE CLINICAL INVESTIGATION (HYPOTHESIS) ................................................ 10
6.1
PRIMARY OBJECTIVES (HYPOTHESIS) ................................................................................................. 10
6.2
SECONDARY OBJECTIVES (HYPOTHESIS) ............................................................................................. 10
7. DESIGN OF THE CLINICAL INVESTIGATION ............................................................................. 10
7.1
POPULATION ................................................................................................................................. 11
7.1.1 SUBJECT POPULATION ..................................................................................................................... 11
7.1.2 INCLUSION CRITERIA ....................................................................................................................... 11
7.1.3 EXCLUSION CRITERIA....................................................................................................................... 11
7.1.4 POINT OF ENROLMENT .............................................................................................................. 11
7.1.5 FEMALES OF CHILDBEARING AGE ....................................................................................................... 11
7.1.6 DURATION OF THE CLINICAL INVESTIGATION ....................................................................................... 11
7.1.7 WITHDRAWAL AND REPLACEMENT OF SUBJECTS .................................................................................. 11
7.1.8 PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION ................................................................. 12
8. METHODOLOGY ................................................................................................................... 12
8.1
TREATMENT DURATION AND MODIFICATION ....................................................................................... 12
8.2
MEDICAL DEVICE ........................................................................................................................... 12
8.2.1 MEDICAL DEVICE AND IT´S CHARACTERISTICS: ..................................................................................... 13
8.2.2 MANUFACTURER (MODEL OR TYPE NUMBER INCLUDING SOFTWARE AND ACCESSORIES): .......................... 13
8.2.3 INSTALLATION AND HANDLING INSTRUCTIONS ..................................................................................... 13
8.2.4 INTENDED USE .............................................................................................................................. 13
8.2.5 IN/DECREASE OF THE TREATMENT FREQUENCY.................................................................................... 13
8.2.6 INTERRUPTION OF THE TREATMENT ................................................................................................... 14
8.2.7 PREMATURE PERMANENT DISCONTINUATION OF THE TREATMENT .......................................................... 14
8.2.8 PROCEDURES FOR SUBJECTS COMPLIANCE .......................................................................................... 14
8.2.9 CONCOMITANT MEDICATION ........................................................................................................... 14
8.2.10 INTERACTIONS, REVERSE REACTIONS AND SIDE EFFECT OF THE MEDICAL DEVICE: ..................................... 14
8.3 RANDOMIZATION AND STRATIFICATION: ...................................................................................... 15
8.4 BLINDING ............................................................................................................................. 15
8.4.1 EMERGENCY PROCEDURE FOR UNBLINDING ........................................................................................ 15
8.4.2 UNBLINDING AT THE END OF THE CLINICAL INVESTIGATION. ................................................................... 15
8.5 BENEFIT AND RISK ASSESSMENT ................................................................................................. 15
8.6 CLINICAL INVESTIGATION PROCEDURES ........................................................................................ 15
8.6.1 GENERAL RULES FOR CLINICAL INVESTIGATION PROCEDURES .................................................................. 15
8.6.2 SCREENING INVESTIGATION.............................................................................................................. 16
8.6.3 TREATMENT .................................................................................................................................. 16
8.6.4 LABORATORY TESTS ........................................................................................................................ 16
8.6.5 END-OF-CLINICAL INVESTIGATION (EOI) EXAMINATION ........................................................................ 16
9. SAFETY DEFINITIONS AND REPORTING REQUIREMENTS ........................................................ 16
9.1
ADVERSE EVENTS (AES)/ADVERSE DEVICE EFFECTS (ADES) ................................................................... 16
9.1.1 SUMMARY OF KNOWN AND POTENTIAL RISKS OF THE MEDICAL DEVICE .................................................... 16
9.1.2 DEFINITION OF ADVERSE EVENT AND ADVERSE DEVICE EFFECT ................................................................ 16
9.2
SERIOUS ADVERSE EVENTS (SAE)/SERIOUS ADVERSE DEVICE EFFECTS (SADES) ........................................ 17
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9.2.1 HOSPITALIZATION – PROLONGATION OF EXISTING HOSPITALIZATION ....................................................... 18
9.2.2 SAES /SADE RELATED TO STUDY-MANDATED PROCEDURES ..................... ERROR! BOOKMARK NOT DEFINED.
9.2.3 PREGNANCY .................................................................................................................................. 18
9.3
SEVERITY OF ADVERSE EVENTS/ADVERSE DEVICE EFFECTS ...................................................................... 18
9.4
RELATIONSHIP TO MEDICAL DEVICE ................................................................................................... 19
9.5
REPORTING PROCEDURES ................................................................................................................ 19
9.5.1 REPORTING PROCEDURES FOR SAES/SADES ...................................................................................... 20
10. FOLLOW-UP ....................................................................................................................... 21
10.1 FOLLOW-UP OF CLINICAL INVESTIGATION PARTICIPANTS INCLUDING FOLLOW-UP OF ADVERSE EVENTS .......... 21
10.2 TREATMENT AFTER END OF CLINICAL INVESTIGATION ............................................................................ 21
11. STATISTICAL METHODOLOGY AND ANALYSIS ...................................................................... 21
11.1 ANALYSIS SETS ............................................................................................................................... 21
11.2 SAMPLE SIZE CONSIDERATIONS ......................................................................................................... 22
11.3 RELEVANT CIP DEVIATIONS .............................................................................................................. 22
11.4 STATISTICAL ANALYSIS PLAN ............................................................................................................. 22
11.5 MISSING, UNUSED AND SPURIOUS DATA ............................................................................................ 22
11.6 ENDPOINTS ANALYSIS ..................................................................................................................... 22
11.6.1 PRIMARY ENDPOINT ANALYSIS ........................................................................................................ 23
11.6.2 SECONDARY ENDPOINT ANALYSIS .................................................................................................... 23
11.6.3 SAFETY AND TOLERABILITY ENDPOINTS ............................................................................................. 23
11.6.4 BASELINE PARAMETERS AND CONCOMITANT MEDICATIONS ................................................................. 23
11.6.5 EXPLORATORY ANALYSES ............................................................................................................... 23
11.7 INTERIM ANALYSIS .......................................................................................................................... 23
11.8 SOFTWARE PROGRAM(S) ................................................................................................................. 23
12. DOCUMENTATION AND DATA MANAGEMENT .................................................................... 23
12.1 DOCUMENTATION OF STUDY RESULTS ................................................................................................ 23
12.1.1 CASE REPORT FORM (CRF) ............................................................................................................ 23
12.1.2 DATA COLLECTION ....................................................................................................................... 24
12.1.3 IDENTIFICATION DATA TO BE CONSIDERED AS SOURCE DATA ................................................................ 24
12.2 SAFEKEEPING ................................................................................................................................ 24
12.3
QUALITY CONTROL AND QUALITY ASSURANCE .................................................................................. 24
12.3.1 PERIODIC MONITORING .................................................................................................................. 24
12.3.2 AUDITS AND INSPECTIONS ............................................................................................................. 25
12.4 REPORTING AND PUBLICATION ......................................................................................................... 25
12.4.1 FINAL REPORT ............................................................................................................................. 25
12.4.2 PUBLICATION OF STUDY RESULTS .................................................................................................... 25
13. ETHICAL AND LEGAL ASPECTS ............................................................................................. 26
13.1 INFORMED CONSENT OF SUBJECTS .................................................................................................... 26
13.2 ACKNOWLEDGEMENT / APPROVAL OF THE CLINICAL INVESTIGATION ....................................................... 26
13.2.1 CHANGES IN THE CONDUCT OF THE CLINICAL INVESTIGATION PLAN ...................................................... 26
13.3 INSURANCE ................................................................................................................................... 27
13.4 CONFIDENTIALITY ........................................................................................................................... 27
13.5 ETHICS AND LEGAL REQUIREMENTS ................................................................................................... 27
13.5.1 DECLARATION OF HELSINKI ............................................................................................................ 27
13.5.2 GOOD CLINICAL PRACTICE (EN ISO 14155) .................................................................................... 27
14. APPENDICES ...................................................................................................................... 29
15. REFERENCES....................................................................................................................... 30
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TABLE 1. VISIT AND ASSESSMENT SCHEDULE
(example - please adapt to your study; this schedule should be a brief summary of the study design)
PERIODS
VISITS
Name
Duration
Number
Name
Time
SCREENING
1
Screening
Days/Weeks
TREATMENT
6 months
2
3
Randomization Control 1
Day 0
Week 2
( 2 days)
4
Control 2
Week 4
( 5 days)
5
Control 3
Week 6
( 2 days)
6
7
Control 4
Month 2
( 5 days)
Control 5
Month 3
( 5 days)
Informed Consent
Inclusion / Exclusion Criteria
Medical History
Concomitant/change in medication
Physical Examination
Body weight and height
Vital Signs (BP, PR)
12-lead ECG
Laboratory Tests
Device related procedures 1.
Device related procedures 2.
Device related procedures 3.
Pregnancy Test
Questionnaires: SF-36 and SHQ
Device Application / Return
Adverse Events
Serious Adverse Events/Serious Device
Effects
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9
8
Control 6
Month 4
( 5 days)
Control 7
Month 5
( 5 days)
10
FOLLOW-UP
28 days
11
End of study
Month 6
( 5 days)
Follow-up 3
Month 7
( 5 days)
Study name/Acronym
Department
5.
INTRODUCTION
5.1
Background information
Provide a brief summary of the disease and conditions that are the focus of your Investigation.
The magnitude, frequency, affected geographical areas, ethnic and gender considerations, etc. of the
disease/condition should be followed by a brief description of the most relevant studies published on
the subject.
5.2
Rationale of the clinical investigation
The Rationale specifies the reasons for conducting the investigation in light of current knowledge. It
should include an explicit documented statement of the need/problem is the base of the project, the
cause of this problem and its possible solutions. It is the equivalent to the introduction in a clinical
investigation plan and it puts the proposal in context. It should answer the question of why and
what: why the investigation needs to be done and what will be its relevance. The magnitude,
frequency, affected geographical areas, ethnic and gender considerations, etc. of the problem should
be followed by a brief description of the most relevant investigations published on the subject as well
as preclinical tests that have been performed on the device to be investigated.
6.
OBJECTIVES OF THE CLINICAL INVESTIGATION (HYPOTHESIS)
6.1
Primary Objectives (Hypothesis)
6.2
Secondary Objectives (Hypothesis)
Goals are broad statements of what the proposal hopes to accomplish. They create a setting for the
proposal. Specific objectives are statements of the research question(s). Objectives should be simple
(not complex), specific (not vague), and stated in advance (not after the research is done). After
statement of the primary objective, secondary objectives may be mentioned. Hypotheses are very
clear-cut statements (Null and Alternative Hypothesis) that can be verified/rejected by a statistical
test.
Objectives may include claims implicit in the intended purpose of the device as well as those made
explicit in labeling, instructions for use or promotional material. It should be clearly stated whether
or not the determinations of long term effects are part of the objectives of the current clinical
investigation.
7.
DESIGN OF THE CLINICAL INVESTIGATION
The design of the study should include information on the type of study, the research population or
the sampling frame, and who can take part (e.g. inclusion and exclusion criteria, withdrawal criteria
etc.), and the expected duration of the study.
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Please provide a schematic diagram.
7.1
Population
7.1.1
Subject population
7.1.2
Inclusion criteria
7.1.3
Exclusion criteria
7.1.4
POINT OF ENROLMENT
7.1.5
Females of childbearing age
7.1.6
Duration of the clinical investigation
For the individual clinical investigation participant
7.1.7
Withdrawal and replacement of subjects
Criteria for withdrawal
Subjects may prematurely discontinue from the clinical investigation at any time. Premature
discontinuation from the study is to be understood when the subject did not undergo EOS
examination and / or all pivotal assessments during the clinical investigation, i.e. three complete
dosage-time profiles.
Subjects must be withdrawn under the following circumstances:
 at their own request
 if the investigator feels it would not be in the best interest of the subject to continue
 if the subject violates conditions laid out in the consent form / information sheet or
disregards instructions by the clinical investigation personal
 or please indicated other reasons (e.g. regarding medical device)
In all cases, the reason why subjects are withdrawn must be recorded in detail in the CRF and in the
subject’s medical records. Should the clinical investigation be discontinued prematurely, all clinical
investigation materials (complete, partially completed and empty CRFs) will be retained.
Follow-up of patients withdrawn from the clinical investigation
In case of premature discontinuation after treatment with the medical device , the investigations
scheduled for the EOS visit will be performed X days after discontinuation. The subjects will be
advised that participation in these investigations is voluntary. Furthermore, they may request that
from the time point of withdrawal no more data will be recorded and that all biological samples
collected in the course of the clinical investigation will be destroyed.
Replacement policy
Please describe procedure of replacement.
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For example: Will patients be replaced (please indicate process e.g. next free subject number will be
allocated...) and/or will drop-outs be included in the sample size…
7.1.8
Premature termination of the clinical investigation
The sponsor has the right to close this clinical investigation at any time. The IEC and the competent
regulatory authority must be informed.
The clinical investigation or single dose steps will be terminated prematurely in the following cases:
 If adverse event/adverse devise effect occur which are so serious that the risk-benefit ratio is
not acceptable
 If the number of dropouts is so high that proper completion of the clinical investigation
cannot realistically be expected.
 Or please indicate other reasons
8.
METHODOLOGY
The methodology section is the most important part of the CIP. It should include detailed information
on the interventions to be made, procedures to be used, measurements to be taken, observations to
be made, laboratory investigations to be done etc. If multiple sites are engaged in a specified CIP,
methodology should be standardized and clearly defined.
Interventions should be described in detail, including a description of the device that is being tested.
The test equipment to be used for the assessment of clinical investigation variables and the
arrangements for monitoring the maintenance and calibrations should be described. Interventions
could also be in the realm of social sciences for example providing training or information to groups
of individuals.
Procedures could be biomedical (collection of blood or sputum samples to develop a diagnostic test),
or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion
as part of formative research, observation of the participant's environment, etc.).
Standardized and/or documented procedures/techniques should be described and bibliographic
references, if not provided earlier should be provided. Instruments which are to be used to collect
information (questionnaires, FGD guides, observation recording form, case report forms etc.) must
also be provided. A list of any other device or medication to be used either during the application of
the device or during the follow up period has to be described.
The measures to be taken to minimize or avoid bias should be explained. In the case of randomized
controlled clinical investigation additional information on the process of randomization and blinding,
description of stopping rules for individuals, for part of the clinical investigation or entire clinical
investigation, the procedures and conditions for breaking the codes etc. should also be described.
A graphic outline of the clinical investigation design and procedures using a flow diagram must be
provided. This should include the timing of assessments.
8.1
Treatment duration and modification
(point of enrolment, to be specified)
8.2
Medical Device
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please adapt for your own clinical investigation/your medical device; information due to your
medical device could be used from Investigator`s Brochure/Manual for Medical Device
In these sections, following issues should be described:
8.2.1
Medical device and it´s characteristics:
8.2.2 Manufacturer (Model or Type Number including software and accessories):
Storage Instructions:
8.2.3
Installation and handling instructions
Including a preparation for use and any intended re-use, maintainance, pre-use checks, precautions
to be taken after use
A summary of necessary training and experience needed for the use of the device.
Delivery & storage conditions of the medical device
If required, please adapt to your clinical investigation!
Packaging and labeling of the medical devise
Packaging shall indicate that the investigational device is exclusively for use in a clinical investigation
according to applicable regulations. Please describe delivery procedures (e.g. shipment of device to
site…).
The labeling should be done according to local legal requirements.
Labels should be written in the local language if required according to local legal regulations
Please indicate a sample label.
Accountability of medical devices
Please indicate handling procedures regarding accountability of the medical device (e.g.
Accountability will be recorded at on-going basis in paper form/source data,
treatment/administration have to be entered in the eCRF too. Furthermore the correct
administration of the device or any variations concerning that will be recorded in the eCRF at each
visit during treatment period.)
8.2.4
Intended Use
please describe in detail!
Initial treatment:
maintenance treatment:
Administration:
Patient diary: specific safety monitoring
8.2.5
In/Decrease of the treatment frequency
If feasible
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8.2.6
Interruption of the treatment
If required, please adapt to your clinical investigation and define the reasons for interruption of the
treatment with the medical device and the following procedures.
8.2.7
Premature permanent discontinuation of the treatment
If required, please adapt to your clinical investigation and define the reasons for premature
permanent discontinuation of the treatment with medical device and the following procedures (End
of Clinical investigation ……..)
Premature permanent discontinuation due to an adverse event
If the reason for premature permanent discontinuation of clinical investigation is an AE, the patient
should have a “Premature EOS” visit with all the assessments performed before the discontinuation
of the treatment with the medical device, whenever possible.
Premature permanent discontinuation due to another reason than adverse event
If the reason for premature permanent discontinuation of clinical investigation is not an AE, the
patient should be withdrawn (withdrawal of consent) and have the EOS visit with all the assessments
performed before the medical device discontinuation, whenever possible.
8.2.8
Procedures for subjects compliance
Please indicate procedures for monitoring subject compliance (e.g. a patient diary will be used)
8.2.9
Concomitant medication
Please adapt details to your own clinical investigation!
e.g.: The well-being of the patient has the first priority, and modifications of concomitant treatment
during the clinical investigation are allowed as necessary. They should be documented in the
patient’s records.
In this clinical investigation, all concomitant medications are allowed, with the exception of:
Allowed:
Not allowed:
Special precautions:
8.2.10 Interactions, reverse reactions and side effect of the medical device:
Please adapt to your device! Information from Investigator`s Brochure/Manual for Medical device
may be used.
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8.3
Randomization and stratification:
If required; please adapt to your own clinical investigation and describe the process of randomization
and the selected system to randomize.
Also provide details on the individual randomization process for clinical investigation participants
e.g.: On day 0 patients are randomized to one of the two groups and the first medical devices are
provided. Please also indicate which randomization procedure will be used
Subjects who replace discontinuing subjects before they had a medical device use on day 1 of the
first investigation period, the substitute subject will receive the same randomization number as the
subject he replaces.
8.4
Blinding
If required; please adapt to your own clinical investigation if required!
Please set a responsible person and describe the procedure of blinding (codes, envelopes …).
8.4.1 Emergency procedure for unblinding
If required; please adapt to your own clinical investigation and define “Emergency” for that
unblinding procedure as well as procedure of unblinding (“Code–breaking-procedure”,” EmergencyEnvelope”.…)
8.4.2 Unblinding -procedure at the end of the clinical investigation.
If required; please adapt to your own clinical investigation and describe procedure of unblinding
(“Code–breaking-procedure”,” Emergency-Envelope”.…).
8.5
Benefit and risk assessment
This point shall include the results of a risk analysis and assessment. This shall describe the balance of
anticipated clinical benefit against the risk associated with the device itself and the procedures
involved in its use
This shall include an analysis of adverse device effects and any history of modification or recall in
relation to safety and clinical performance in relation to both the device under investigation and
devices described.
8.6
Clinical investigation procedures
8.6.1
General rules for clinical investigation procedures




All clinical investigation measures like blood sampling and measurements (vital parameters,
ECG, etc.) have to be documented with date (dd:mm:yyyy).
In case several clinical investigation procedures are scheduled at the same time point, there
is no specific sequence that should be followed.
The dates of all procedures should be according to the CIP. The time margins mentioned in
the clinical investigation flow chart are admissible. If for any reason, a clinical investigation
procedure is not performed within scheduled margins a CIP deviation should be noted, and
the procedure should be performed as soon as possible or as adequate.
If it is necessary for organizational reasons, it is admissible to perform procedures which are
scheduled for one visit at two different time points. Allowed time margins should thereby
not be exceeded.
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8.6.2
Screening investigation
Please provide Information on the procedures taking place at the screening investigation
8.6.3
Treatment
8.6.4
Laboratory Tests
Provide detailed information on the different tests and procedures performed during the clinical
investigation. E.g. Laboratory tests, ECGs, Physical examination, etc.
8.6.5
End-of-clinical investigation (EOI) examination
e.g.: After treatment period (X month) patients undergo the end-of-clinical investigation examination
that entails …
9.
SAFETY DEFINITIONS AND REPORTING REQUIREMENTS
9.1
Adverse event (AE)/adverse device effect (ADE)
9.1.1
Summary of known and potential risks of the medical device
Provide a summary of all known adverse events and risks of the medical device and other
interventions (preferably in a table). Use the Investigator`s Brochure.
In addition to adverse event reporting, non-medical complaints such as malfunction, misuse, use
error not leading to an adverse event, shall be documented throughout the clinical investigation and
shall be reported as specified by local law.
All complaints of a non-medical nature shall be handled under the sponsor's quality management
system.
9.1.2
Definition of adverse event and adverse device effect
An Adverse Event (AE) is any adverse change from the subject's baseline condition, i.e. any
unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease
which is considered to be clinically relevant by the physician that occurs during the course of the
study, whether or not considered related to the medical device.
Adverse event include:
 Exacerbation of a pre-existing disease.
 Increase in frequency or intensity of a pre-existing episodic disease or medical condition.
 Disease or medical condition detected or diagnosed after treatment with the medical device
even though it may have been present prior to the start of the clinical investigation.
 Continuous persistent disease or symptoms present at baseline that worsen following the
start of the clinical investigation.
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



Lack of efficacy in the acute treatment of a life-threatening disease.
Events considered by the investigator to be related to clinical investigation-mandated
procedures.
Abnormal assessments, e.g., ECG and physical examination findings, must be reported as AEs
if they represent a clinically significant finding that was not present at baseline or worsened
during the course of the clinical investigation.
Laboratory test abnormalities must be reported as AEs if they represent a clinically significant
finding, symptomatic or not, which was not present at baseline or worsened during the
course of the clinical investigation lead to interruption or permanent discontinuation of
medical device.
Adverse events do not include:
 Pre-planned interventions or occurrence of endpoints specified in the CIP are not considered
AEs, if not defined otherwise.
 Medical or surgical procedure, e.g. surgery, endoscopy, tooth extraction, transfusion.
However, the event leading to the procedure is an AE. If this event is serious, the procedure
must be described in the SAE narrative.
 Pre-existing disease or medical condition that does not worsen.
 Situations in which an adverse change did not occur, e.g., hospitalizations for cosmetic
elective surgery or for social and/or convenience reasons.
 Misuse of either medical device or concomitant medication without any signs or symptoms.
However, misuse must be mentioned in the Medical Device Inventory/ Treatment Log.
An Adverse Device Effect (ADE) is any adverse event related to the use of an investigational medical
device. This includes any adverse event resulting from insufficiencies or inadequacies in the
instructions for use, the deployment, the implantation, the installation, the operation, or any
malfunction of the investigational medical device.
Furthermore this includes any event that is a result of a use error or intentional misuse.
9.2
Serious adverse event (SAE)/ Serious adverse device effect (SADE)
A Serious Adverse Event (SAE)/Serious adverse device effect is defined as any AE/ADE fulfilling at
least one of the following criteria:
 leads to a death,
 leads to a serious deterioration in the health of the subject that
1) resulted in a life-threatening illness or injury,
2) resulted in a permanent impairment of a body structure or a body function,
3) required in-patient hospitalization or prolongation of existing hospitalization,
4) resulted in medical or surgical intervention to prevent permanent impairment to body
structure or a body function.
 leads to foetal distress, foetal death or a congenital abnormality or birth defect.
 is an important medical event that may not immediately result in death, be life-threatening,
or require hospitalization but may be considered as SAEs/SADEs when, based upon
appropriate medical judgment, it may jeopardize the subject and may require medical or
surgical intervention to prevent one of the outcomes listed in the definitions above.
 shows the occurance of a malignant tumor (§3 (16) MPG).
Life-threatening refers to an event in which the subject was at risk of death at the time of the event.
It does not refer to an event that hypothetically might have caused death if it were more severe.
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9.2.1
Hospitalization – Prolongation of existing hospitalization
Hospitalization is defined as an overnight stay in a hospital unit and/or emergency room.
An additional overnight stay defines a prolongation of existing hospitalization.
The following is not considered an SAE/SADE and should be reported as an AE/ADE only:
 Treatment on an emergency or out subject basis for an event not fulfilling the definition of
seriousness given above and not resulting in hospitalization.
The following reasons for hospitalizations are not considered AEs, and therefore not SAEs:
 Hospitalizations for cosmetic elective surgery, social and/or convenience reasons.
 Standard monitoring of a pre-existing disease or medical condition that did not worsen, e.g.,
hospitalization for coronary angiography in a subject with stable angina pectoris.
 Elective treatment of a pre-existing disease or medical condition that did not worsen, e.g.,
hospitalization for chemotherapy for cancer, elective hip replacement for arthritis.
9.2.2
Pregnancy
Any pregnancy that occurs during study participation must be reported to the sponsor. To ensure
subjects safety, each pregnancy must be reported to the sponsor immediately. A pregnancy must
be followed up to determine outcome (including premature termination) and status of mother and
child. Pregnancy complications and elective terminations for medical reasons must be reported as an
AE. Spontaneous abortions must be reported as an SAE.
Any SAE occurring in association with a pregnancy brought to the investigator’s attention after the
subject has completed the study and considered by the investigator as possibly related to the
investigational product, must be promptly reported to the sponsor.
In addition, the investigator must attempt to collect pregnancy information on any female partners
of male study subjects who become pregnant while the subject is enrolled in the study.
9.3
Severity of adverse events/adverse device effects
The severity of clinical AEs /ADEs is graded on a three-point scale: mild, moderate, severe, and
reported on specific AE pages of the CRF.
If the severity of an AE/ADE worsens during medical device administration, only the worst intensity
should be reported on the AE page. If the AE lessens in intensity, no change in the severity is
required.
Mild
Event may be noticeable to subject; does not influence daily activities; the AE /ADE resolves
spontaneously or may require minimal therapeutic intervention;
Moderate
Event may make subject uncomfortable; performance of daily activities may be influenced;
intervention may be needed; the AE/ADE produces no sequelae.
Severe
Event may cause noticeable discomfort; usually interferes with daily activities; subject may not be
able to continue in the study; the AE/ADE produces sequelae, which require prolonged therapeutic
intervention.
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A mild, moderate or severe AE/ADE may or may not be serious. These terms are used to describe the
intensity of a specific event (as in mild, moderate, or severe myocardial infarction). However, a
severe event may be of relatively minor medical significance (such as severe headache) and is not
necessarily serious. For example, nausea lasting several hours may be rated as severe, but may not
be clinically serious. Fever of 39°C that is not considered severe may become serious if it prolongs
hospital discharge by a day. Seriousness rather than severity serves as a guide for defining regulatory
reporting obligations.
9.4
Relationship to medical device
For alls, the investigator will assess the causal relationship between the medical device and the AE
using his/her clinical expertise and judgment according to the following algorithm that best fits the
circumstances of the AE:
Unrelated
 May or may not follow a reasonable temporal sequence from administration of the study
product
 Is biologically implausible and does not follow known response pattern to the suspect
medical device (if response pattern is previously known)
 Can be explained by the known characteristics of the subject’s clinical state or other modes
of therapy administered to the subject.
Unlikely
 There is a reasonable temporal relation between the AE and the medical device, but there is
a plausible other explanation for the occurrence of the AE.
Possibly
 Follows a reasonable temporal sequence from administration of the medical device.
 The AE may equally be explained by the study subject’s clinically state, environmental or
toxic factors, or concomitant therapy administered to the study subject.
 The relationship between the medical device and AE may also be clinically plausible.
Probably
 Follows a reasonable temporal sequence from administration of the medical device, and
plausible reasons point to a causal relation with the medical device.
Related
 Follows a reasonable temporal sequence form administration of the medical device.
 Follows a known response pattern to the medical device (if response pattern is previously
known).
 No other reasonable cause is present.
Not assessable
 The causal relationship between the medical device and the AE can not be judged.
9.5
Reporting procedures
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A special section is designated to adverse events in the case report form. The following details must
thereby be entered:
 Type of adverse event
 Start (date and time)
 End (date and time)
 Severity (mild, moderate, severe)
 Serious (no / yes)
 Unexpected (no / yes)
 Outcome (resolved, resolving, not resolved, resolved with sequelae, unknown, fatal)
 Relation to medical device (Related/ Probably/ Possibly/ Unlikely/ Not related/ Not
assessable)
Adverse events are to be documented in the case report form in accordance with the above
mentioned criteria.
9.5.1
Reporting procedures for SAEs/SADEs
In the event of serious, the investigator has to use all supportive measures for best patient
treatment. A written report is also to be prepared and made available to the clinical investigator
immediately.The following details should be at least available:






Patient number
Patient: initials, age in years, sex
The suspected medical device
The adverse event assessed as serious
Short description of the event and outcome
Device related or non-device related
The written report is divided into two parts:
 Initial report: Informs about what has happened (AE/ADE assessed as serious), if there is a
relationship to the medical device, and which action was set.
 Follow up-Report: informs about the outcome
The Sponsor is responsible for the classification of adverse events and ongoing safety evaluation of
the clinical investigation and shall:
 review the investigators assessment of all adverse events and determine and document in
writing their seriousness and relationship to the investigational device
 review all devices deficiencies and determine and document in writing whether they could
have led to a serious adverse device effect
 report or ensure the reporting of all SAEs, wheter or not related to the medical device, to the
EC and regulatory authorities (AGES)!
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10.
FOLLOW-UP
10.1 Follow-up of clinical investigation participants including follow-up of adverse
events
The clinical investigation plan must give a clear indication of what follow up will be provided to the
research participants and for how long.
This may include a follow up, especially for adverse events, even after data collection for the clinical
investigation is completed.
10.2
Treatment after end of clinical investigation
Please adapt to your clinical investigation! Describe whether there is a treatment after end of clinical
investigation or not, and describe their treatment in the event of expiry
11.
STATISTICAL METHODOLOGY AND ANALYSIS
The clinical investigation plan should provide information on how the data will be managed, including
data handling and coding for computer analysis, monitoring and verification. The statistical methods
proposed to be used for the analysis of data should be clearly outlined, including reasons for the
sample size selected, power of the study, level of significance to be used, procedures for accounting
for any missing or spurious data etc. For projects involving qualitative approaches, specify in
sufficient detail how the data will be analyzed.
Please also indicate criteria for termination of the clinical investigation.
11.1
Analysis sets
Define the analysis sets used in detail
e.g.
Two different analysis sets are defined:
Intention to treat set
This analysis set includes subjects who were randomized and received at least one dose medical
device
This analysis set should preferably be chosen for efficacy and safety assessment
Per-protocol set
This analysis set comprises all subjects who were treated with the medical device (at least one dose)
and did not violate the CIP in a way that might affect the evaluation of the effect of the medical
device on the primary objective, i.e., without major CIP violations.
Define allowed CIP violations as comprehensive as possible (for instances specify the percentage of
treatment with medical device necessary etc.)
In certain circumstances this set can be employed in the analysis of efficacy variables.
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11.2
Sample size considerations
Provide information about the sample size you have chosen for your study.
A formal sample size calculation employing established biometric methods should preferably be
presented. The statistical test used as well as the alpha-error and the power of this calculation should
be presented. The underlying data for the calculation (i.e. expected difference, variation of the
primary outcome) should be supported by a literature reference. The sample size calculation should
be based on the primary outcome (justification is needed if another endpoint is chosen).
If no formal sample size calculation is performed, the sample size should at least be strongly justified
in detail with supporting literature.
11.3
Relevant CIP deviations
Please describe, how potential CIP deviations will be assessed and classified into minor and major
deviations and how to deal with these deviations (e.g. major deviations regarding to subjects safety
will lead to withdrawal).
Major and minor CIP deviations will be identified by medically trained staff before the study closure.
All CIP deviations will be listed in the study report.
No deviations from the CIP and of any type will be made without complying with all IRB/EC
established procedures in accordance with applicable regulations.
11.4
Statistical analysis plan
Please adapt to your study.
A statistical analysis plan (SAP) will provide full details of the analyses, the data displays and the
algorithms to be used for data derivations. The SAP furthermore will include definitions of major and
minor CIP deviations and the link of deviations to the analysis set, which also will be covered in the
final study report.
Procedures of reporting any deviations from the original statistical plan (any deviations from the
original statistical plan should be described and justified in the CIP and/or in the final report, as
appropriate.
11.5
Missing, unused and spurious data
Please describe and justify, how to deal with missing, unused and spurious data.
Please describe the statistical methods in place for missing or unused data (e.g. last observation
carried forward) as comprehensive as possible.
11.6
Endpoints analysis
Provide details about the primary and secondary endpoint analyses, including the statistical tests
that will be used
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11.6.1 Primary endpoint analysis
11.6.2 Secondary endpoint analysis
11.6.3 Safety and tolerability endpoints
11.6.4 Baseline parameters and concomitant medications
11.6.5 Exploratory analyses
11.7
Interim analysis
Specify if an interim analysis is performed and give alpha and power for this analysis. State if this
analysis is done for futility only or also for efficacy.
Criteria for the termination of the clinical invetigation:
Please provide statistical reasoning (e.g. thresholds for the interim analysis) for study termination. If
applicable.
11.8
Software program(s)
12.
DOCUMENTATION AND DATA MANAGEMENT
12.1
Documentation of study results
A subject screening and enrollment Log will be completed for all eligible or non-eligible subjects with
the reasons for exclusion.
12.1.1 Case report form (CRF)
Please indicate whether a “Paper-CRF*” or an”e-CRF” will be used and adapt section below to your
study.
For each subject enrolled, regardless of medical device initiation, a CRF must be completed and
signed by the principal investigator or co-investigator. This also applies to those subjects who fail to
complete the study. If a subject withdraws from the study, the reason must be noted on the CRF.
Case report forms are to be completed on an ongoing basis.
CRF entries and corrections will only be performed by study site staff, authorized by the investigator.
In a “Paper-CRF” all forms should be completed using a black pen and must be legible*. Errors
should be crossed out but not obliterated, the correction inserted, and the change initialed and
dated by the investigator, co-investigator or study nurse.
The entries will be checked by trained personnel (Monitor) and any errors or inconsistencies will be
checked immediately.
The monitor will collect original completed and signed CRFs at the end of the study. A copy of the
completed and signed CRFs will remain on site.
Please indicate a responsible person, to whom original CRF´s would be passed.
f.e.: Data Manager…
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Special provisions may apply for electronic CRFs
12.1.2 Data Collection
Data collected at all visits are entered into an interactive form. The CRFs will be source documents
verified following guidelines established before study onset as detailed in the Monitoring Plan.
Maintenance of the study database will be performed by ……
Please adapt for your own study
12.1.3 Identification data to be considered as source data
Please indicate if any data to be considered to be source data and therefore to be directly entered on
the CRF.
12.2
Safekeeping
The investigator will maintain adequate and accurate records to enable the conduct of the study to
be fully documented and the study data to be subsequently verified. These documents will be
classified into two different categories: investigator's file, and subject clinical source documents.
The investigator's file will contain the CIP/amendments, IB/Manual for Medical Device, CRFs (eCRF
printout), standard operation procedures (SOPs), data clarification and query forms, EC/IRB and
Health Authority approval with correspondence, informed consent, drug records, staff curriculum
vitae and authorization forms, screening and enrollment logs, and other appropriate
documents/correspondence as per EUROPENAN Standard of EN ISO 14155 (incl. GCP) and local
regulations.
Subject clinical source documents include, but are not limited to subject hospital/clinic records,
physician’s and nurse’s notes, appointment book, original laboratory reports, ECG, X-ray, pathology
and special assessment reports, consultant letters, etc.
These two categories of documents must be kept on file by the investigator for as long as needed to
comply with national and international regulations. If source documents are not durable as long as
needed (e.g. ECG printouts) they must be preserved as a copy. No study document should be
destroyed without prior written approval from the Department of ……
When source documents are required for the continued care of the subject, appropriate copies
should be made for storing outside of the site.
12.3
Quality Control and Quality Assurance
Please adapt to your own study
12.3.1 Periodic Monitoring
The monitor will contact and visit the investigator regularly and will be allowed, on request, to have
access to all source documents needed to verify the entries in the CRFs and other CIP-related
documents provided that subject confidentiality is maintained in agreement with local regulations. It
will be the monitor's responsibility to inspect the CRFs at regular intervals throughout the study, to
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verify the adherence to the CIP and the completeness, consistency and accuracy of the data being
entered on them. The monitoring standards require full verification for the presence of informed
consent, adherence to the inclusion/exclusion criteria, documentation of SAEs/SADEs and the
recording of the main efficacy, safety, and tolerability endpoints.
To be ISO 14155 compliant at least 3 monitoring visits are scheduled. An initiation visit, one routine
visit and a final visit after the last patient had finished the study. The monitor will be working
according to SOPs and will provide an ISO 14155-compliant monitoring report after each visit for the
sponsor and the investigator. Depending on the quality of the data, additional monitoring visits will
be necessary according to the sponsor’s discretion.
Monitoring will be performed by…………
Please adapt for your own studyPlease indicate the number and frequency of planned monitoring
visits as well as the planned percentage of “Source Data Verification” (SDV).
e.g: 6 monitoring visits are planned ; monitoring visits will be performed every 6 weeks, 100% of
source data will be checked by the monitor (which means 100% SDV).
12.3.2 Audits and Inspections
Upon request, the investigator will make all study-related source data and records available to a
qualified quality assurance auditor mandated by the sponsor or to regulatory authority inspectors.
The main purpose of an audit or inspection is to confirm that the rights and welfare of the subjects
have been adequately protected, and that all data relevant for assessment of safety and efficacy of
the investigational product have appropriately been reported to the sponsor.
12.4
Reporting and Publication
Please adapt to your own study.
12.4.1 Final report
Within one year after the final completion of the study, a full Final Report will be written
by………………………..
(please indicate the responsible person for this issue)
The Principal Investigator will be asked to review and sign the Final Report.
12.4.2 Publication of study results
(Example; please adapt to your own study):
The findings of this study will be published by the sponsor (investigators) in a scientific journal and
presented at scientific meetings. The manuscript will be circulated to all co-investigators before
submission. Confidentiality of subjects in reports/publications will be guaranteed.
You can also mention here who will be first author or corresponding author and determine who
qualifies for authorship. Timelines (e.g.: writing of the full article within 6 months after finishing the
study) can also be given.
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13.
ETHICAL AND LEGAL ASPECTS
13.1
Informed consent of subjects
Following comprehensive instruction regarding the nature, significance, impact and risks of this
clinical investigation, the patient must give written consent to participation in the study.
During the instruction the patients are to be made aware of the fact that they can with-draw their
consent – without giving reasons – at any time without their further medical care being influenced in
any way.
In addition to the comprehensive instructions given to the patients by the investigator, the patients
also receive a written patient information sheet in comprehensible language, explaining the nature
and purpose of the study and its progress.
The patients must agree to the possibility of study-related data being passed on to relevant
authorities.
The patients must be informed in detail of their obligations in relation to the proband insurance in
order not to jeopardize insurance cover.
13.2
Acknowledgement / approval of the clinical investigation
The investigator (or a designated CRO) will submit this CIP and any related document provided to the
subject (such as subject information used to obtain informed consent) to an Ethics Committee (EC) or
Institutional Review Board (IRB). Approval from the committee must be obtained before starting the
clinical investigation, and should be documented in a dated letter to the investigator.
Serious Adverse Events /Serious Adverse Device Effects have to be reported to the ethics committee
and to the Austrian Agency for health and Food Safety (AGES).
Adverse events / Adverse device effects- whether serious and/or unexpected, and possibly
endangering the safety of the study participants are likewise to be reported to the ethics committee.
The clinical investigation shall be performed in full compliance with the valid legal regulations
according to the Medical Device Law (MPG Medizinproduktegesetz as actual amendet) of the
Republic of Austria and the ISO 14155 (as actual amended)
The study must be notified to the Austrian Agency for Health and Food Safety (AGES) and Ethics
Committee.
13.2.1 Changes in the Conduct of the Clinical Investigation Plan
Amendments of the clinical investigation plan
Proposed amendments must be submitted to the appropriate CA and ECs. Substantial amendments
may be implemented only after CA/EC approval has been obtained. Amendments that are intended
to eliminate an apparent immediate hazard to subjects may be implemented prior to receiving CA/EC
approval. However, in this case, approval must be obtained as soon as possible after implementation.
Termination of the clinical investigation
If the sponsor or the investigator decides to terminate the clinical investigation before it is
completed, they will notify each other in writing stating the reasons of early termination. In
terminating the study, the sponsor and the investigator will ensure the adequate consideration is
given to the protection of the subject interests. The investigator, sponsor or designated CRO will
notify the relevant regulatory authorities and EC. Documentation will be filed in the Trial Master
(Clinical Investigation) clinical investigationand Investigator Files.
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13.3
Insurance
During their participation in the clinical investigation the patients will be insured as defined by legal
requirements. The principal investigator of the clinical investigation will receive a copy of the
insurance conditions of the 'patients insurance'. The sponsor is providing insurance in order to
indemnify (legal and financial coverage) the investigator/center against claims arising from the
clinical investigation, except for claims that arise from malpractice and/or negligence. The
compensation of the subject in the event of clinical investigation-related injuries will comply with the
applicable regulations.
Details on the existing patients insurance are given in the patient information sheet.
Please indicate insurance details
13.4
Confidentiality
Please adapt to your own study.
The information contained in this document, especially unpublished data, is the property of the……...
It is therefore provided to you in confidence as an investigator, potential investigator, or consultant,
for review by you, your staff, and an Ethics Committee or Institutional Review Board. It is understood
that this information will not be disclosed to others without written authorization from………….,
except to the extent necessary to obtain informed consent from those persons to whom the medical
device may be treated with.
13.5
Ethics and legal requirements
13.5.1 Declaration of Helsinki
The investigator will ensure that this study is conducted in full conformance with the principles of the
"Declaration of Helsinki" (as amended at the 56th WMA General Assembly, Tokyo, Japan, 2008).
13.5.2 Good Clinical Practice (EN ISO 14155)
ISO 14155 addresses good clinical practices for the design, conduct, recording and reporting of
clinical investigations carried out in human subjects to assess the safety and performance of medical
devices for regulatory purposes .
It specifies general requirements intended to:
 protect the rights, safety and well-being of human subjects,
 ensure the scientific conduct of the clinical investigation and the credibility of the clinical
investigation results,
 assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other
 bodies involved in the conformity assessment of medical devices.
The principal investigator of the clinical investigation shall guarantee that only appropriately trained
personnel will be involved in this. All clinical investigations must follow the EUROPENAN Standard of
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EN ISO 14155 and, if applicable, the Code of Federal Regulations (USA). In other countries in which
EN ISO Guidelines exist, the investigators will strictly ensure adherence to the stated provisions.
Therefore this study follows the EN ISO Guidelines embedded in the Austrian medical device act.
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14.
APPENDICES

e. g. Informed Consent Form ( Version; Date ), Manual of medical Device, IB etc.
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15.
REFERENCES
Provide References in Vancouver Style (http://www.icmje.org/)
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