Questions and Answers RDC 10/2015 - NIH Collaboratory · PDF file · 2017-04-27Questions and Answers RDC 10/2015 v. 1 Brasília, 16/Mar/2016. ... medical device without registration

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Questions and Answers RDC 10/2015

v. 1

Brasília, 16/Mar/2016.

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Copyright © 2015. Brazilian Health Surveillance Agency. The partial or full reproduction of this work is allowed, as long as the source is quoted. Legal Deposit at National Library, as per Decree no. 1825 dated 20 December 1907. General Management of Technology in Healthcare Products Leandro Rodrigues Pereira Coordination of Clinical Research in Healthcare Products Alessandro Ferreira do Nascimento

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Table of Contents

Table of Contents ............................................................................................................... 3

1. Introduction .................................................................................................................. 2

2. Submission .................................................................................................................. 3

3. Amendments, Changes, Suspensions, and Cancelling .............................................. 10

4. Quality Aspects .......................................................................................................... 13

5. Import ......................................................................................................................... 14

6. Deadlines ................................................................................................................... 16

7. Reports ...................................................................................................................... 17

8. Adverse Events .......................................................................................................... 19

9. Miscellaneous ............................................................................................................ 20

Frequently Asked Questions – RDC 10/2015 2

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1. Introduction

This document aims to present questions received up to the moment about Brazilian

Collegial Board of Governors’ Resolution (RDC) 10/2015 by all service channels of Anvisa,

with no harm to the existent determinations in current regulations.

Its preparation was done in sections that gather the questions regarding a theme.

Some of the questions could fit in multiple sections, however, to ease access, no question

was duplicated in more than one section.

New questions received will be assessed to subsidize the review of the document

and subsequent publication of new version, at each update.

Abbreviations used in this document have the same meaning as those described in

RDC 10/2015 and in manuals related to the rule.


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2. Submission

1. May the documents to be petitioned at Anvisa be submitted in foreign

language?

As determined by the Manual for Submission of Dossier of a Medical Device

Clinical Investigation (DICD) and Clinical Trial-Specific Dossier, we recommend that

all documentation is submitted in Portuguese, especially the clinical protocol and

the investigator’s brochure, once the appraiser in the technical area may prepare a

requirement requesting the free translation of the documentation submitted.

2. As soon as a DICD is filed, is there a deadline for petitioning a clinical trial-

specific dossier?

There is no deadline defined, if at the moment of analysis of a DICD there is no

specific dossier attached, a requirement will be prepared. As per RDC 10/2015:

“Article 9 The sponsor must submit a DICD to ANVISA

only in case it intends to perform clinical trials with medical

devices in domestic territory.

Sole paragraph. For purposes of DICD analysis, at least

one clinical trial-specific dossier to be performed in Brazil

must be filed.”

3. In the submission of DICD by a CRO representing the sponsor that does not

have an affiliate in Brazil, is it necessary to present in the dossier a letter of

delegation of responsibilities from the sponsor to the CRO?

As per Article 43, §2, of RDC 10/2015: Any roles related to the clinical trial that

are transferred to a CRO and undertaken by it should be specified in writing in a

document signed by the sponsor and the CRO.


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4. Item “h” of ANNEX II of RDC 10/2015 informs that: “In case the investigational

medical device already has registration in Brazil, only information that

subsidizes the proposed post-registration changes should be submitted in

the DICD”. If the investigational medical device had already been submitted to

Anvisa for registration application, but it is still waiting for analysis, should all

data regarding the investigational medical device be submitted in the DICD?

Yes. As the medical device still does not have the registration approved, all

data should be submitted. However, we request that in the dossier, the information

that the medical devices awaits for registration approval is described and that the

respective registration process number by GGTPS/ANVISA is informed.

5. What should be petitioned or filed manually?

All petitions should be performed electronically. Regarding filing, only for the

DICD it should be done manually. All other documents (clinical trial-specific

dossiers and secondary petitions) should be filed electronically. Therefore, for the

DICD, the petition is electronic and the filing is manual. For the other documents,

both petitioning and filing are electronic.

6. Should a new DICD be submitted to Anvisa in case the sponsor decides to

study use indications different from those determined in the plan?

No. Any changes related to the same medical device remains part of the same

DICD, only the clinical trial that will be created to assess this new use indication

should be filed as a CLINICAL TRIAL-SPECIFIC DOSSIER.

7. How should the submission be done in case of a clinical trial that involves a

medical device without registration in Brazil besides the investigational

device?

If the objective of the clinical trial involves assessing the safety and efficacy of

the investigational device, but uses other devices not registered in Brazil, the

sponsor of the clinical trial should submit the same technical information related to

the investigational device for the other devices without registration used in the

clinical trial.


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8. Observational and post-marketing trials, susceptible to submission by

notification, need to be linked to a DICD?

For cases in which the medical device already has a petitioned DICD, the

electronic Notification process should be filed using the petitioning code 80105 –

CLINICAL TRIALS – NOTIFICATION OF CLINICAL TRIAL – MEDICAL DEVICES

linking to the corresponding DICD. The mentioned link should be performed

informing in field 17 of the form the DICD process number to which the clinical trial

is linked. If there is no link to any DICD, the referred field should be completed with

the wording: NOT APPLICABLE.

9. When a trial, that was approved by RDC 39/2008, is linked to a DICD, will

Anvisa inform the company that filed the clinical trial about this link?

No. It is the sponsor’s responsibility to inform the delegated companies about

this link.

10. Is it possible to register a trial in a database other than those mentioned in

Article 4 and Item VII of Article 14 of RDC 10/2015? In case the proof of

registration in the international database is not yet available, is it acceptable

to send a letter along with the dossier explaining such situation and, in the

future, to add to the process the proof of registration in the international

database?

There are no exceptions to what is determined in the rule. As per Article 4 and

Item VII of Article 14 of RDC 10/2015, the proof of registration of the clinical trial in

the registration database of International Clinical Trials Registration Platform/World

Health Organization (ICTRP/WHO) or other databases acknowledged by the

International Committee of Medical Journal Editors (ICMJE) should be presented.


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11. A site that does not have its own Brazilian Health Establishment Roll (CNES),

but it is linked to an institution that has one, may use the CNES of the

institution to which it is linked?

In such case, it is acceptable to submit the CNES of the institution to which the

site is linked.

12. In approvals due to course of time (as per Article 11), will there not be

issuance of a Special Notice (CE) after the release of the Document for Import

of Investigational Products of the DICD?

In approvals due to course of time, a Document for Import of Investigational

Product(s) of the Dossier of Clinical Investigation of Medical Device (DICD) will be

issued. However, in such case, there is no issuance of CE. The CE will only be

issued if this study is effectively assessed by Anvisa after the course of time.

13. Will the CE be updated upon each submission of clinical protocol? Will the

company that filed the clinical trial receive the updated CE?

The CE or the Document for Import of Investigational Product(s) of DICD will be

updated upon each submitted protocol. For any update of CE or Document for

Import, only the company that filed the DICD will receive this documentation. It is

the responsibility of this company to submit the updated document to the

companies that filed the clinical trial-specific dossiers.

14. Is it possible to pay the fee as an individual (investigator-sponsor)?

No. the investigator-sponsor should always be represented along with Anvisa

by the Institution to which he/she is linked, as per Section III, Chapter VI of RDC

10/2015.


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15. In case one wishes to conduct a clinical trial for a new use indication with an

investigational medical device that is already registered, how to proceed to

check if the medical device has a DICD submitted or approved by ANVISA?

If the intended clinical trial fits in the scope of the rule, i.e., clinical trial with

medical device for purposes of registration (in this case, post-registration change),

the trial should be presented via DICD according to the instructions determined in

RDC 10/15 (as per Article 2).

To check if the product already has a DICD submitted or approved by Anvisa, it

is necessary to consult the medical device registration holder and check if they

authorize the applicant to use information previously submitted by them. In case the

registration holder does not authorize the use of this information, the investigator-

sponsor should submit to Anvisa a rationale (literature data, non-clinical trials) to

support the proposed development.

16. In case one wishes to conduct a post-marketing clinical trial with a medical

device that is already registered in other countries, but not registered in

Brazil, which would the submission process be?

Considering that RDC 10/2015 has as scope the clinical trials with the aim to

subsidize the registration of an investigational medical device, the conduction of

clinical trials involving medical devices not registered in Brazil, that have

characteristics of post-marketing research, due to the fact that involve medical

devices already registered in other countries, will be considered as clinical trials

susceptible to submission of a DICD, considering that such products are not

registered in Brazil.


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17. Information about CROs requested in item 58 of the Clinical Trial Submission

Form refers to CROs contracted for Brazil or for all participating countries?

Only for Brazil.

18. Regarding Article 52 of RDC 10/2015: “In case of donation of investigational

medical devices not registered in Brazil for conduction of clinical trial, the

donor shares the sponsor’s responsibilities”, however, how will ANVISA treat

the relation between the device donation process and the responsibility or not

of the donor?

The responsible for submitting the clinical trial to ANVISA may present a

statement indicating that data produced in the trial will not be used to subsidize the

registration or post-registration changes in the scope of ANVISA by the donor

(manufacturer) or legal representative in Brazil, and that there is no agreement of

data supply/monitoring of the clinical trial involving the donor/manufacturer. In case

there is a relationship of co-responsibility involving a sponsor unrelated to the

institution, established by a donation of medical devices and/or data

supply/monitoring of the clinical trial, a document of delegation that determines

responsibilities in the same manner as it is established between the investigator-

sponsor and the institution in paragraph 2 of article 50 of RDC 10/2015 will be

essential to be prepared.

19. In case some information requested in RDC 10/2015 is not yet available due to

the stage of development of the experimental drug, is it acceptable to explain

the absence of such information and submit it to Anvisa when it become

available?

It is known that the amount and detailing of documentation are directly related

to the phase of development. Thus, its absence may be justified. However, if this

information is essential for approval of the DICD, a request will be prepared and the

analysis will only be finished after the information submission.


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20. Is it possible to send, along with the request fulfillment, information that has

been updated or changed in the period between the requirement notification

and its fulfillment? (E.g.: Change of shelf-life)

No. Changes should be submitted according to the specific subject.

21. How to proceed in cases when a later phase trial (pivotal, for example) is

submitted and there is still an ongoing previous phase trial (feasibility)?

If the results of the previous phase trials are essential for the beginning of the

later phase trial, it is necessary to wait for its closure. On the contrary, submission

of the trials may be done concurrently.

22. In the checklist of all electronic petitions, the CD-ROM and the proof of

payment (or exemption) of the Inspection Fee are listed as one of the

documents to be sent. Considering that this is an electronic petition, do they

need to be submitted?

No. These two items should automatically be unavailable in an electronic

petition. However, due to a system issue, these fields appear as available for

document upload. We suggest, in this case, that the company adds to the fields of

CD-ROM and Proof of Payment a pdf document with the rationale (e.g.: “Not

applicable”). This error is under verification with Anvisa IT department.

RECOMMENDATIONS:

Aiming at easing the analysis of the DICD, we recommend to:

Include a general table of contents to ease the search for documents

Include clarification notes, if applicable, to justify the absence of a document

in the corresponding section or to inform that a certain document or certain

information is in another section.


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3. Amendments, Changes, Suspensions,

and Cancelling

23. What is the difference between subject codes for amendments submitted by

RDC 39/2008 and RDC 10/2015?

As per RDC 39/2008, all amendments should be submitted as notification, with

the subject code 1395 CLINICAL TRIALS – Notification of amendment to the

Clinical Research Protocol. As this is a notification, there is no fee payment.

As per RDC 10/2015, only substantial amendments should be submitted with

the specific subject code. The subject code to be used is 80113 CLINICAL TRIALS

– Substantial Amendment to Clinical Protocol – Medical Devices. In such case, as

the amendment is open to approval by Anvisa, there is payment of fee. Non-

substantial amendments should be submitted in the annual report of monitoring of

the clinical trial.

It is important not to confuse the subject codes, once this may generate a new

submission of document and delay in its analysis and approval.

24. Which is the subject code for notification of change of principal investigator

and inclusion or exclusion of sites by RDC 10/2015?

This type of change should be notified using the subject code 80112 –

CLINICAL TRIALS – Change of Clinical Trial Submission Form – Medical Devices.

This type of change does not generate the issuance of a new CE. However, it is

important a prompt update so that information is used in a proper manner in GCP

inspections.

25. How to submit an extension study and an ongoing extension study?

The extension of an ongoing study is done via non-substantial amendment, as

long as the same recruited participants, same design, methods, and objectives of


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the original project are maintained. In case there is a change in these parameters or

a new protocol as an extension study, a clinical trial-specific dossier should be

petitioned linked to a DICD. Therefore, an extension study is a non-substantial

amendment and an extension study represents a new clinical trial-specific dossier.

26. Substantial amendments should continue to be submitted even after the end

of the trial in Brazil?

In this case, there is no need to submit them. However, in case there is a new

protocol to be linked to the DICD, these amendments should be submitted.

27. How to proceed in cases when a substantial amendment to be petitioned still

does not have a REC approval letter?

In case of impossibility of submission of the Approval Opinion, at the moment of

the submission of the petition for substantial amendment, the absence of the

document should be dully justified. The absence of the REC approval letter will be

reason for issuance of requirement for request of the missing document. As per

RDC 23, dated 5 June 2015, the deadline for fulfillment of the prepared requirement

will be of one hundred and twenty (120) days, non-extendable, counted as of the

date of confirmation of the requirement receipt. Anvisa will only approve the

amendment after the submission of the REC approval letter.

28. In case there is a substantial modification to the DICD that may also be

considered as a substantial amendment to the clinical trial, will there be

payment of fee for both petitions? Is it possible to reduce one of the fees?

Yes, there will be payment for both petitions. Subjects related to fees should be

discussed with the Management of Collection Management (GEGAR) of Anvisa.

29. In case there is change to the information regarding the investigational

products (e.g., change in the storage/sterilization conditions) and there are

several trials being conducted, will the change be petitioned for each clinical

trial, additionally to the DICD?

Yes, this change should be petitioned for each clinical trial that was affected by

the change. The subject code to be used is 80112 – CLINICAL TRIALS – Change

of Clinical Trial Submission Form – Medical Devices.


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For the DICD, in case the change configures as substantial change, it should

also be petitioned as such.

30. Which changes in the form may be submitted in the annual report and

development report as reported in the Manual for submission of changes,

amendments, suspensions, and cancelling?

None of the changes of forms should be submitted in the annual report or

development report, but rather, at the moment when there is change of data. The

subject code to be used is 80112 – CLINICAL TRIALS – Change of Clinical Trial

Submission Form – Medical Devices (for specific change to a clinical trial) or 80111

– CLINICAL TRIALS – Change of Petition Form of DICD for change of DICD data).

31. In the Manual for submission of changes, amendments, suspensions, and

cancelling, the “Change in the investigational product” is mentioned as an

example of substantial amendment. Would not this example be of change to

the DICD?

Yes, this is substantial change to the DICD, which may also be considered as a

substantial amendment.


cancelling, the “Change to the clinical protocol design” is mentioned as an

example of substantial amendment. Could this change be also a substantial

change?

No, once there is no inclusion of protocol unanticipated or different from the

established one or any other situation defined as substantial change. We highlight

that, in case there is an update to the development plan, this would configure as a

non-substantial change and, therefore, it should be submitted at the moment of

submission of the Development report of the investigational medical device.


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cancelling, the “Change to the documentation used by the study team for data

capture and record” is mentioned as an example of non-substantial

amendment. However, this type of information is not in the protocol.

This change in the documentation would be, for example, to change the paper

Case Report Form to an electronic one. However, for better clarity, this example will

be removed from the next version of the manual.

34. The approval of substantial amendments, which do not cause changes to the

CE, will be informed by ANVISA via letter to the sponsor?

An updated CE will be submitted informing the new version of the protocol

regarding the evaluated amendment.

4. Quality Aspects

1. Which information is required in the label templates? Is there any law on this

matter?

There are no specific rules about labels for clinical trials in the scope of

ANVISA. RDC 10/2015 only requires that the label template is submitted.

2. Regarding the label template, it should be presented in the specific dossiers

of each clinical trial or in the DICD?

The rule is that the label template be presented in the DICD. However, if the

template changes between trials, the label template may be presented in the

specific dossier of each clinical trial and a clarification note should be attached to

the DICD to inform that the label templates are in the specific dossiers.


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3. Regarding labeling of a comparator medical device to be used in a clinical

trial, if the medical device is purchased in Brazil, may its original labeling be

maintained or is it necessary to include a label with different label sayings to

identify that the device is used in a clinical trial?

Aspects related to study blinding should be considered, therefore, if the trial is

open-label, there is no need for a new label to the comparator medical device

already registered.

4. Is it necessary for the production line to be certified for GMP upon the

production of an investigational medical device?

No. RDC 10/2015 requires that the production occurs under GMP conditions,

but the certification is not required.

5. In international trials, it is common to use medical devices registered in other

countries, but not yet registered in Brazil. Could this medical device be used

as a comparator?

For studies investigating new medical devices, in case a comparator medical

device not registered in Brazil is issued, a rationale for the choice of comparator

should be presented, along with adequate technical documentation assuring the

safe use of this device in the clinical trial.

5. Import

1. In order a trial approved by RDC 39/2008 becomes effective by RDC 10/2015, it

should be listed in the DICD CE. Products to be imported will be listed in this

CE and such information may be gathered in the Form of Estimate of the

Amount of Import of RDC 39/2008. However, for the majority of products to be

imported, there is no information on the storage conditions and shelf-life,

which are also described in the CE of RDC 10/2015. In this case, how will such

information be described?

For trials approved under RDC 39/2008 that will be part of a DICD and that will

need the import of investigational products, we request a Clinical Trial Submission

Form (FAEC) to be submitted petitioning the subject code 80112 – CLINICAL

TRIALS – Change of Clinical Trial Submission Form – Medical Devices in the

clinical trial consent process.


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2. As per RDC 10/2015, will there no longer be pre-shipment authorization? Are

PAFs prepared for the new type of import?

In the context of the old RDC 39/2008, the CE was issued without the

description of products to be imported, because it was listed in the Import License

requests, assessed separately and individually. As per the new RDC 10/2015, pre-

shipment authorization is no longer applicable. Now, all products to be imported, for

all clinical trials, will be described in the CE, CEE, or Import Document. Thus, each

Clinical Trial Submission Form (FAEC) submitted along with the specific dossiers

should contain all products to be imported for that trial. CE, CEE, or Import

Document, issued for the DICD, will contain the complied of all products. Import

will be mediated only by the health authority in the clearance site.

The preparation of RDC 10/2015, especially regarding import, was done along

with the Superintendence of Customs Ports, Airports, and Borders (SUPAF).

Additionally, COPEA conducted trainings in the PAFs of greater impact to assure all

procedures are harmonized and conducted without any problems.


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3. How should observational trials without import of investigational medical

device, but involving import and export procedures of other investigational

products be submitted to ANVISA?

Observational trials without import of investigational medical devices, but

involving import/export procedures should be notified as 80105 – CLINICAL

TRIALS – Notification of Clinical Trial – Medical Devices.

6. Deadlines

1. In the process of analysis of DICD, will all additions submitted before the

issuance of CE, whether substantial or not, be considered in the initial

analysis?

That depends on the moment when these petitions occur. If it is possible for

them to be considered before the initial manifestation, they will be assessed before

the issuance of the CE. On the contrary, they will be analyzed according to

deadlines in Article 36.

2. What is the deadline for analysis of a clinical trial-specific dossier?

If the filing of the dossier happens before the beginning of analysis of a DICD,

the deadline is the same as for the DICD (i.e., under Article 11 of RDC 10/2015). In

case a specific dossier had been filed during the analysis of DICD, the assessment

of this dossier will depend on whether the analysis of the DICD is almost done or in

the beginning. In case the DICD analysis is in conclusion phase, the specific

dossier will follow the same logic described in the paragraph below.

If the filing is after approval or in the beginning of the DICD, the deadline will

depend on the following situation:

If it is a protocol already determined in the plan, there is no legal deadline

for analysis. However, this protocol will be assessed in a shorter time than

that for the analysis of a DICD;


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If it is a protocol nor determined in the plan, it configures as substantial

change. In this case, the deadline follows what is determined in Article 42 of

RDC 10/2015.

3. As per Article 29 of RDC 10/2015, when there is request for reactivation of

suspended clinical trial protocols or DICD, these may be reinitiated only after

Anvisa approval. What is the estimate for such approval?

There is no legal estimate. The time for analysis will be determined on a case-

by-case basis (will depend on the nature of the event that caused the suspension

and also on the corrective measures adopted by the sponsor). However, in case, in

the future, it is possible to identify an average of time for analysis, we may provide

an estimate.

7. Reports

1. What is the difference between the annual and final monitoring reports of the

clinical trial protocol and the investigational medical device development

report?

The annual report refers to data from the national sites and the final report

refers to data from all participating sites. These reports are related to a clinical trial.

The investigational medical device development report involves an assessment of

the status of development of the medical device, considering worldwide aspects,

i.e., the report should present details in the regulatory scope (registration in other

countries), device changes history, safety assessment considering adverse events

occurred with the investigational medical device, clinical development status

considering all clinical trials performed in worldwide scale with the investigational

device.


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2. What happens to the DICD after the end of the development plan and

registration of the medical device?

The DICD remains with the same status until new protocols are linked, whether

any substantial change is petitioned or it is suspended or cancelled.

3. Article 56 in RDC 10/2015 mentions that “The sponsor or the independent

Data Monitoring Committee should systematically collect and assess data

from adverse events occurred in the clinical trial, submitting to ANVISA in the

annual reports”. The independent Data Monitoring Committee issues one

letter per clinical trial; this letter should be submitted along with the DSUR for

all clinical trials approved in the DICD or should it be submitted in the annual

report of the clinical trial?

What is expected in the investigational medical device development report to be

listed the result of the data collected and assessed by the sponsor or independent

Data Monitoring Committee in that period, and the description of actions taken due

to safety reasons.

Regarding the letters involving recommendations issued by the independent

Data Monitoring Committee for clinical trials, they will be sent in the annual

monitoring report of each clinical trial.

4. When a trial approved by RDC 39/08 becomes effective by RDC 10/2015,

which reference date for annuality should be considered for the submission

of annual monitoring reports of the clinical trial? The date under RDC 39/2008

or the one under RDC 10/2015?

The same date used in RDC 39/08 should be used, i.e., the date of approval of

the CE issued under RDC 39/08.


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8. Adverse Events

1. How should the causal relationship of the adverse event (AE) to the

investigational products be established, as per Article 61?

The causal relationship for investigational medical device, comparator or

placebo should be described in the form used for the AE. For other investigational

products, the causal relationship, if applicable, should be described in the case

narrative.

2. Will Notivisa be changed to meet the requirement in Article 58? When will the

manual for submission of adverse events be released?

Notification of adverse events continues to be done via the electronic clinical

research system in Anvisa website, as currently. The current form did not need to

be changed, and any adopted measures unavailable in the system options should

be described in the report narrative. This manual is in final review phase and will be

published soon.

3. Article 66 informs that “The sponsor should assure all relevant information

about adverse events mentioned in Article 63, that are fatal or life-threatening,

is documented and notified to ANVISA, by an electronic form, within 7

calendar days as of the date of acknowledgement of the case by the sponsor.

Sole paragraph. Additional information on the monitoring of adverse events

mentioned in the caput should be included in the form within 8 calendar days

of its notification”. After the first monitoring report (Follow-up 1) is informed

in NOTIVISA within 8 calendar days as of the notification of the initial case,

what is the deadline for notifying the other monitoring reports (Follow-up 2, 3,

4, and so on)?

The notification of serious adverse events is done via the electronic system of

clinical research on Anvisa website – and should not happen via NOTIVISA. For

subsequent updates of the notification, there is no determined deadline, but

monitoring should be done (and updated in the system) until resolution or

stabilization of the adverse event, as per Article 62 of RDC 10/2015.


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4. Article 63 mentions that “the sponsor should notify Anvisa, via a specific

electronic form, unexpected serious adverse events occurred in the domestic

territory, which causality is possible, probable or defined regarding the

investigational product”. Should the provided information already contain

unblinding?

No. Unblinding should be defined by the very sponsor in the clinical trial

protocol.

9. Miscellaneous

1. Due to the increasing amount of requirements related to statistical aspects of

the clinical trial, which are the minimum requirements necessary for

statistical analysis?

The protocol should follow item 8.8 in the Document of Americas. Background

for the choice of main aspects of the trial should be provided, such as the

calculation of sample size (including the used formula, parameters, parameter

references and limits), study endpoints, limits (clarification about the definition of

limit including reference from previous trials and clinical relevance) and definition of

statistical hypotheses in data analysis.

2. Some protocols present their own definitions or different definitions for

protocol deviation. In this case, may the protocol definition be followed?

Yes. The definition of deviation may be that specified in the protocol, however,

ANVISA may reevaluate this definition.

3. From which moment is a clinical trial approved under RDC 39/2008

considered as included in the DICD and should follow RDC 10/2015 (as per

Article 80)? What is the impact of the clinical trial if it is not included in a

DICD?


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The clinical trial approved by RDC 39/2008 should follow RDC 10/2015 when

there is issuance of CE of the DICD or issuance of the Document for Import of

Investigational Product of the DICD.

Trials approved under RDC 39/2008 follow the sayings of this resolution until

they are included in a DICD. In case the trial is not included in a DICD until its

closure, there is no impact to it, because it will continue to follow RDC 39/2008 until

its closure. Secondary petition subject codes specific to RDC 39/2008 remain

available for such cases.

Documents

Questions and Answers RDC 10/2015 - NIH Collaboratory · PDF file · 2017-04-27Questions and Answers RDC 10/2015 v. 1 Brasília, 16/Mar/2016. ... medical device without registration