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Advice from BAREC regarding the retention periods for study documents in clinical research

Written by Editor on . Posted in General.

This recommendation was endorsed by the College during the plenary meeting of 10/10/2025

Context

This short guideline provides an overview of the retention periods that apply to study documents within research projects, in accordance with applicable legal requirements. These retention periods may vary depending on the type of study involved.

General Data Protection Regulation (GDPR)

REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

Article 5

Personal data shall be: kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) subject to implementation of the appropriate technical and organisational measures required by this Regulation in order to safeguard the rights and freedoms of the data subject (‘storage limitation’);

Clinical Trials Regulation (CTR)

REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

Article 58

Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial. However, the medical files of subjects shall be archived in accordance with national law.

Medical Device Regulation (MDR)

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

ANNEX XV (CLINICAL INVESTIGATIONS)

CHAPTER III

Article 3

The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical investigation with the device in question has ended, or, in the event that the device is subsequently placed on the market, at least 10 years after the last device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.

In-vitro Diagnostic Regulation (IVDR)

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

ANNEX XIV (INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES)

CHAPTER II

Article 3

The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market.

Belgian Act of 7 May 2004 on Experiments involving the human person

NL: Royal Decree (RD) – 30 JUNI 2004. – Koninklijk besluit tot bepaling van uitvoeringsmaatregelen van de wet van 7 mei 2004 inzake experimenten op de menselijke persoon voor wat betreft klinische proeven met geneesmiddelen voor menselijk gebruik.

Fr : 30 JUIN 2004. – Arrêté royal déterminant des mesures d’exécution de la loi du 7 mai 2004 relative aux expérimentations sur la personne humaine en ce qui concerne les essais cliniques de médicaments à usage humain

NL: Artikel 24

De opdrachtgever en de onderzoeker bewaren de essentiële documenten in verband met een klinische proef tot ten minste 20 jaar na de voltooiing ervan.

Fr: Article 24

Le promoteur et l’investigateur conservent les documents essentiels relatifs à un essai clinique pendant au moins 20 ans après son achèvement.

The Royal Decree of 30 June 2004 states that “essential documents related to a clinical trial must be retained for at least 20 years after its completion.” This specifically refers to clinical trials. However, since the Clinical Trials Regulation (CTR) came into force, the retention period for study documents related to clinical trials is now 25 years after the end of the clinical trial.

In other words, there is no legally defined retention period for experiments in general. Each sponsor is responsible for determining an appropriate (minimum) retention period and must specify this in the study documents, such as the protocol and informed consent form (ICF).

When setting this retention period, several motivations can be taken into account: compliance with GDPR, alignment with CTR, environmental considerations (reducing unnecessary long-term storage, especially of physical documents, contributes to a more sustainable research practice and lowers the ecological footprint), cost-efficiency (defining a realistic and justified retention period helps avoid unnecessary storage costs, particularly for paper archives or secure digital systems),…

These motivations can be balanced depending on the type of research, institutional policy, and legal context. Ultimately, transparency and clarity in defining the chosen retention period are key.

Summary

Study type or applicable lawInformation about retention period
GDPRNo longer than is necessary for the purposes for which the personal data are processed
CTRAt least 25 years after the end of the clinical trial.
MDRFor a period of at least 10 years after the clinical investigation with the device in question has ended for a period of at least 10 years after the last device has been placed on the market. Implantable devices: at least 15 years.  
IVDRFor a period of at least 10 years after the clinical investigation with the device in question has ended for a period of at least 10 years after the last device has been placed on the market.  
ExperimentsNo legally defined retention period

Advice for hospital sites_on_involvement of local EC

Written by Editor on . Posted in General.

Dit advies werd goedgekeurd door het College tijdens de plenaire vergadering van 10/10/2025

BAREC heeft kennisgenomen van de brief van het College d.d. 1 december 2023 betreffende de interne “green light” procedures die sommige ziekenhuisinstellingen hanteren via hun lokaal EC. BAREC wenst hierbij haar visie en aanbeveling te formuleren.

We verwijzen naar artikel 70 van de Wet van 10 juli 2008 betreffende de gecoördineerde wet op de ziekenhuizen en andere verzorgingsinrichtingen:

 Art. 70. – Om te worden erkend, moet ieder ziekenhuis beschikken over een plaatselijk ethisch comité, met dien verstande dat de Koning de voorwaarden kan omschrijven onder dewelke bedoeld comité via een samenwerkingsakkoord tussen ziekenhuizen mag aangeboden worden.
Het comité oefent volgende opdrachten uit telkens het een verzoek in die zin ontvangt :
  1°) een begeleidende en raadgevende opdracht met betrekking tot de ethische aspecten van de ziekenhuiszorg;
  2°) een adviserende opdracht met betrekking tot alle protocollen inzake experimenten op mensen en op reproductief menselijk materiaal.
  De hierboven bedoelde opdrachten kunnen door de Koning, na advies van de Nationale Raad voor Ziekenhuisvoorzieningen, nader worden gepreciseerd.
  De Koning kan, na advies van de Nationale Raad voor Ziekenhuisvoorzieningen, de voorwaarden, regelen en modaliteiten bepalen onder dewelke de in 2° bedoelde opdracht gezamenlijk dient uitgevoerd te worden door de ethische comités van meerdere ziekenhuizen.
  De Koning bepaalt, na advies van de Nationale Raad voor Ziekenhuisvoorzieningen, de samenstelling en de werking van het plaatselijk ethisch comité.

BAREC begrijpt dat instellingen de verplichting uit bovenstaand artikel wensen na te leven en erkent hun intentie om hun lokaal EC te informeren over lopende of geplande klinische studies. Tegelijkertijd benadrukt BAREC dat het geldende wettelijke kader – met name de Clinical Trial Regulation (CTR, EU nr. 536/2014) en de Wet van 7 mei 2017 betreffende klinische proeven met geneesmiddelen voor menselijk gebruik – in België bepaalt dat de beoordeling van klinische proeven exclusief toekomt aan een onafhankelijk ethisch comité.

BAREC deelt bovendien de bezorgdheid van het College dat interne procedures binnen instellingen er niet toe mogen leiden dat de effectieve evaluatie of de opstart van een klinische proef wordt vertraagd.

Ons advies aan de Belgische EC’s en ziekenhuisinstellingen is dan ook het volgende:

  • Indien een instelling ervoor kiest om een interne procedure te behouden of te introduceren, moet zij garanderen dat deze geen vertragend effect heeft op de uitvoering van een klinische proef.
  • Lokale informatie- of adviesmomenten kunnen nuttig zijn, maar dienen te gebeuren parallel of voorafgaand aan de wettelijke indiening, en niet als bijkomende voorwaarde ná een positief advies en goedkeuring.

Met dit advies wil BAREC meewerken aan een praktische balans tussen transparantie en efficiëntie.

BAREC a pris connaissance de la lettre du Collège datée du 1er décembre 2023 concernant les procédures internes « green light » que certaines institutions hospitalières appliquent via leur comité d’éthique local (EC). BAREC souhaite, par la présente, formuler sa vision et ses recommandations à ce sujet.

Nous renvoyons à l’article 70 de la loi du 10 juillet 2008 relative à la loi coordonnée sur les hôpitaux et autres établissements de soins :

Art.70 . – Pour être agréé, chaque hôpital doit disposer d’un comité local d’éthique, étant entendu que le Roi peut définir les conditions dans lesquelles ce comité peut fonctionner dans le cadre d’un accord de collaboration entre hôpitaux.

Le comité exerce les missions suivantes, lorsque la demande lui en est adressée :

1°) une mission d’accompagnement et de conseil concernant les aspects éthiques de la pratique des soins hospitaliers;

2°) une fonction d’avis sur tous protocoles d’expérimentations sur l’homme et le matériel reproductif humain.

Les missions visées ci-dessus peuvent être précisées par le Roi, après avis du Conseil national des Etablissements hospitaliers.

Le Roi peut, après avis du Conseil national des Etablissements hospitaliers, fixer les conditions, règles et modalités selon lesquelles la mission visée au 2° doit être exécutée conjointement par les comités d’éthique de plusieurs hôpitaux.

Le Roi fixe, après avis du Conseil national des Etablissements hospitaliers, la composition et le fonctionnement du comité local éthique.

BAREC comprend que les institutions souhaitent se conformer à l’obligation mentionnée dans l’article ci-dessus et reconnaît leur intention d’informer leur comité d’éthique local des études cliniques en cours ou prévues. Dans le même temps, BAREC souligne que le cadre juridique en vigueur — notamment le Règlement relatif aux essais cliniques (CTR, UE n° 536/2014) et la loi du 7 mai 2017 relative aux essais cliniques de médicaments à usage humain — stipule qu’en Belgique, l’évaluation des essais cliniques relève exclusivement d’un comité d’éthique indépendant.

BAREC partage en outre la préoccupation du Collège selon laquelle les procédures internes au sein des établissements ne doivent pas avoir pour effet de retarder l’évaluation effective ou le démarrage d’un essai clinique.

Notre recommandation aux comités d’éthique belges et aux établissements hospitaliers est donc la suivante :

  • Si un établissement choisit de maintenir ou d’introduire une procédure interne, il doit garantir que celle-ci n’ait aucun effet retardateur sur la mise en œuvre d’un essai clinique.
  • Les moments d’information ou de consultation locale peuvent être utiles, mais ils doivent avoir lieu en parallèle ou en amont de la soumission légale, et non comme condition supplémentaire après un avis favorable et approbation.

Par cet avis, BAREC souhaite contribuer à établir un équilibre entre transparence et efficacité.

BAREC statement for the sponsors and EC’s on the collection of ethnicity data in clinical trials

Written by Editor on . Posted in Ethnicity, Geen categorie.

This advice was endorsed by the College during the plenary meeting of 10/10/2025.

The participants in a clinical trial should reflect the target population. Adequate reporting of ethnicity can potentially contribute to better understanding of cultural, social, and biological differences, enabling the identification of population groups disproportionately affected by certain diseases, along with genetic information collected from study participants.

  • Elements in favor of collecting these data in clinical trials/studies:
    • Increased cultural and racial diversification in Europe. The number of clinical trials worldwide has surged, yet clinical trial populations often lack sufficient diversity, which can lead to incomplete or skewed medical data.
    • Crucial to include study populations reflecting the general population’s diversity in terms of age, sex, ethnicity, and lifestyle. Documentation thereof is necessary.
    • Subgroups may respond differently to medicinal products/devices.
    • Possible risk of subgroups not/disproportionately represented in the trial.
    • Adequate reporting can potentially contribute to better understanding of cultural, social, and biological differences.
  • Clinical trials/studies considering the collection of ethnicity data should provide:
    • Clear justification for doing so, explicitly stated in the study protocol and ICF. The collection of ethnicity data must be scientifically relevant and comply with GDPR principles.
    • Detailed plans on how  ethnicity will be defined, measures to promote diversity, how the information will be collected and handled, the option to refuse collection on these data, measures to avoid, identify and address discrimination,…
    • Appropriate safeguards to protect participants’ privacy and ensure data confidentiality.
  • It is crucial to:
    • communicate to participants the importance of voluntarily providing these sensitive data.
    • ensure that individuals have the freedom to decide whether they wish to share such information.
  • Ethics Committees should verify compliance with these principles in the ICF and the protocol.

We would also like to refer to the advice nr. 17 of the Belgium’s Advisory Committee on Bioethics: https://www.health.belgium.be/en/node/46162

Note on Terminology – Ethnicity versus Race

  • This advice specifically refers to the collection of ethnicity data, not race.
  • Though still in use in the Anglo-Saxon culture and language, the European Union rejects theories which attempt to determine the existence of separate human races. BAREC thus elected not to use this term in any of its documents (e.g ICF template).
  • Given this cultural difference, the use of the term ‘racial origin’/’race’ in a protocol however does not imply an acceptance of such theories. If an Anglo-Saxon sponsor chooses to use the term race in the study protocol, BAREC does not consider it necessary to systematically request changes to this terminology, as long as it is applied respectfully and within the applicable legal and ethical frameworks.
  • The term “race” should however not be used in any patient facing documents.
  • BAREC expects EC’s to critically assess its appropriateness within the specific study context.

Lifting of traceability of samples HBM

Written by Editor on . Posted in Advice, Traceability.

This advice was endorsed by the College Board on 14/11/2025.

Question

What should be included in the informed consent form (ICF) regarding lifting of traceability of samples, and what is the rationale for including it?

Answer

Lifting of traceability or the anonymizing of samples means that the samples can no longer be traced back to the donor. It is important to understand that lifting the traceability of samples has legal implications, especially with regard to the rights of the donor.

Donors (patients and/or healthy volunteers) should be informed of the consequences of the lifting of traceability, as it results in the waiver of important rights. An explicit consent process should be in place, ensuring that the donor is fully aware of his/her options regarding the lifting of traceability of his/her samples and the related legal consequences.

This implies that the sponsor should have a system in place to track whether or not the donor has consented to the lifting of traceability of his/her samples.

We rely on several guidelines and legal frameworks for this advice.

Law of December 19th, 2008, regarding human biological material (HBM law)

The central principle of the Law of December 19th 2008 regarding the procurement and use of human biological material intended for human medical applications or for scientific research purposes (hereinafter: “HBM law”), is the principle of traceability of samples. In short, this means that all actors involved should be able to localize and identify human biological material in each and every step of the way. (art. 2, 23 HBM law). In case samples are being anonymized, the traceability inevitably gets lost.

Therefore, the HBM law explicitly requires that the lifting of traceability of samples collected from living
donors is subject to the condition of obtaining the donor’s consent.

This principle is also mentioned as such in the Biobank Compendium.

In addition to the traceability principle, the HBM law also grants the donor the right to be informed of the meaningful information that results from analyses performed on his/her samples. (art. 11 HBM law). If the samples are anonymized, this right to receive meaningful information acquired from the analysis of his/her samples automatically expires.

Art. 22, §7 of the HBM law in that regard states that :

(…) kan de beheerder van het menselijk lichaamsmateriaal in de biobank de traceerbaarheid van het menselijk lichaamsmateriaal te allen tijde opheffen :

1° indien de donor of de persoon die bevoegd is om toestemming voor de wegneming en het gebruik te verlenen hiervoor zijn voorafgaande toestemming heeft gegeven; indien het onmogelijk is om de toestemming te vragen voor het opheffen van deze traceerbaarheid, of indien deze vraag uitzonderlijk ongeëigend zou zijn, dan dient het positief advies te worden verkregen van een volledig erkend ethisch comité (…);

2° De beheerder heft de traceerbaarheid van het menselijk lichaamsmateriaal op indien het bestemd is voor de bewerking tot geartificialiseerd of geëxtraheerd materiaal dat niet bestemd zal zijn voor, of niet zal gebruikt worden in het kader van genetisch onderzoek (…) en waarop artikel 3, § 5, eerste lid, van toepassing zal zijn. De opheffing van deze traceerbaarheid geldt uitsluitend ten aanzien van de donor van wie het menselijk lichaamsmateriaal dat tot bedoeld materiaal wordt verwerkt afkomstig is en geldt niet ten aanzien van de leveranciers van bedoeld materiaal.

Wanneer wordt vastgesteld dat er aanleiding is tot de toepassing van artikel 11, mag de traceerbaarheid slechts worden opgeheven nadat de in dat artikel bedoelde procedure volledig is nageleefd.”

“(…) le gestionnaire du matériel corporel humain au sein de la biobanque peut lever à tout moment la traçabilité du matériel corporel humain :

1° si le donneur ou la personne habilitée à accorder son consentement pour le prélèvement et l’usage a préalablement donné son consentement à cet effet; s’il est impossible de demander le consentement pour la levée de cette traçabilité, ou si cette demande était exceptionnellement inappropriée, l’avis positif doit alors être obtenu d’un comité d’éthique avec agrément complet (…);

2° Le gestionnaire lève la traçabilité du matériel corporel humain si celui-ci est destiné à être traité en vue d’obtenir du matériel artificialisé ou extrait qui ne sera pas destiné à la recherche génétique ou utilisé dans ce cadre et auquel l’article 3, § 5, alinéa 1er, s’appliquera. La levée de cette traçabilité s’applique exclusivement à l’égard du donneur dont provient le matériel corporel humain qui est traité pour obtenir le matériel visé et non à l’égard des fournisseurs du matériel visé.

Lorsqu’il est constaté qu’il y a lieu d’appliquer l’article 11, la traçabilité ne peut être levée qu’une fois que la procédure visée à cet article a été entièrement respectée. ”

Belgian Advisory Committee on Bioethics

In addition, the “Belgian Advisory Committee on Bioethics” states in its advice nr. 45 that the samples do not fall under the donor’s ownership but that the donor always retains a determination right (in Dutch: “bestemmingsrecht”). This means that the donor should always be aware of the purposes for which his/her samples are being used and that he/she has to give his/her consent for any use of its samples. If the donor’s samples are being anonymized, this determination right automatically expires.

Law of August 22nd, 2002 regarding Patients’ Rights

More in general, the Law of August 22nd 2002 on patient rights states that a patient has the right to know all information required to understand his/her health status and the evolution thereof (art. 7 Law regarding Patients’ Rights).

Conclusion

In the light of the above mentioned laws and ethical guidelines, a person participating in prospective clinical research should be able to consent to the anonymization of his/her samples because in case the donor consents, he/she waives several rights (i.e. the traceability requirement, the determination right and the right to be informed of meaningful information). If the donor does not consent to anonymization, this must be recorded in the ICF, and procedures should be in place to ensure that the samples are not anonymized.

In the ICF template for clinical trials in adult patients, the above is included in section 13.2. Although the HBM Law expressly excludes clinical research from its scope under Article 3, §3(f), the underlying principles relating to traceability and its lifting remain relevant and should apply mutatis mutandis to samples collected in clinical trials or other prospective research. The significant implications of lifting traceability for donors’ rights justify requiring prior consent from participants in these contexts.

Paediatric clinical trials: single parent or both parents’ signature needed?

Written by Editor on . Posted in Paediatric clinical trials.

This advice was endorsed by the College Board on 20/06/2025
v2 dd 04JUL2025

Under the EU Clinical Trials Regulation, the informed consent of a singular legally designated representative is sufficient for enrolling a minor in a clinical trial. Belgian law, through the Clinical Trials Law of 7 May 2017 and the Law of 22 August 2002 on Patients’ Rights, clarifies that this representative must be someone who exercises parental authority or is the child’s legal guardian.

According to Articles 373 and 374 of the Belgian Civil Code, parental authority is typically exercised jointly by both parents, regardless of whether they live together. In practice, each parent is presumed to act with the consent of the other, unless a court has ruled otherwise. While this legal presumption facilitates everyday decisions, it may not be appropriate for high-stake matters such as the clinical trial participation of a minor.

It is therefore ethically recommended to obtain written consent from both parents, particularly if the study may have significant implications for the child or family. In the Informed Consent Form (ICF), two signature lines should be present.

Simultaneous signing is not required. The parent that is present at the on-site visit can take the ICF home which gives the other parent the opportunity to sign it too. Sufficient time should be given to participants and parents to consider before signing the ICF, allowing for both signatures to be obtained at a later time.

The ethical principle of respect for autonomy thus suggests that efforts should be made to obtain consent from all relevant parties whenever possible.

However, there may be situations where obtaining written consent from both parents is not feasible or appropriate, such as when one parent is unavailable (e.g. when one parent is deceased, is in jail, in single-parent households,…), or estranged and there is no indication for the principal investigator (directly or indirectly) that the absent parent has a different opinion about the participation of the child in the study. In such cases, it may be ethically permissible to proceed with obtaining written consent from a single parent, provided that prior efforts have been made to involve and inform both parents and that the decision is made in the best interest of the child.

In that case, the parent that is present at the on-site visit should be asked if the co-parent would agree to the inclusion of the child in the study. If only one parent signs, it must be clear to that single parent that his/her written consent implies the consent of the other absent parent of the child/minor. It is good practice to document in the ICF that the single parent present then signs either in his/her own capacity, or on behalf of both parents, including the rationale behind.

If the principal investigator has knowledge of refusal of the other parent to allow the child to participate in the study, the principal investigator cannot include the child without the written consent of the other parent, even not if the single parent has signed on behalf of both parents.

It’s essential to approach these situations with sensitivity and ensure that decisions are made in the best interest of the child.

Q&A Pregnancy follow-up

Written by Editor on . Posted in Pregnancy.

This Q&A was approved by the College Board on 20/06/2025
v1 dd 04JUL2025

Question

What should be considered in the follow-up of a pregnant participant and pregnant partner in an interventional clinical trial?

Answer

In a clinical trial, a new medicinal product is being investigated. In order to optimise the knowledge about any potential teratogenic or embryotoxic/foetotoxic effects of a medicinal product and the doses and concentrations at which such effects will develop, it is desirable to gather information and to monitor both pregnant participants/partners and their offspring.

Pregnant participant

The majority of medicinal products or chemical substances administered to a pregnant woman could have effects on the foetus either before the placenta is fully developed or subsequently, if they can cross the placenta to at least some extent. Medicinal products may have a different impact at different stages of pregnancy.

The follow-up of a pregnant participant is subject to pharmacovigilance requirements. This means that the study sponsor is obligated to monitor and report all adverse events, including those occurring during pregnancy, to the competent authorities. Efforts should be made to collect data on the drug effects as well as the outcome for both mother and fetus.

Consent for the follow-up of the pregnant participant’s health condition and the processing of personal data is not requiredto the extent there is a legal obligation to report the adverse event. In such cases, the legal basis under the GDPR would be Article 6(1) (c) of the GDPR (legal obligation) and the justification for the processing of special category data would be Article 9(2)(i) of the GDPR (reasons of public interest related to public health to ensure high standards of quality and safety of health care and of medicinal products or medical devices). This has been confirmed by both the EU Commission (in Q3, 1) and the European Data Protection Board (in section 2.1) for clinical trials under the CTR.

Even though there might not be an obligation to collect consent for the processing of personal data, data subjects always need to be informed about the processing of their personal data (Article 13 and 14 GDPR).

On the other hand, an informed consent form (ICF) for the follow-up of the health status of the (born) child for drug safety purposes is necessary (“infant authorization”). It is preferable to obtain two signatures on the specific ICF for further follow-up of the child (see also: https://barec.be/paediatricclinical-trials-single-parent-or-both-parents-signature-needed/), although this follow-up can also be included in the Main ICF signed by the participant upon joining the clinical trial.

Pregnant partner

The follow-up of a pregnant partner involves collecting data on the health and development of the pregnant partner (and optionally the child) without interventions. This follow-up should be detailed in the clinical trial protocol of the CTR-study, including the duration of the follow-up (including that of the child). The follow-up should be specified in time, e.g. until x months after birth.

Written consent from the pregnant partner is required (unless it concerns purely the registration of a product’s safety and there is a legal obligation to report the adverse event).

This follow-up falls under the Law of May 7, 2004, on experiments on the human person. We refer to Article 62 of the Advisory Committee on Bioethics, which notes that the clinical trial (interventional drug study (e.g. CTR-study)) in which a male participant is involved is distinct from the observational study set up in case of his partner’s pregnancy (monitoring effects on pregnancy). These are two separate studies, but they can and should be described within a single study protocol of the CTR-study.

While elements of earlier guidance—such as Article 62 of the Advisory Committee on Bioethics—date from before the implementation of the CTR and may not fully reflect the current regulatory context, they still provide useful considerations. BAREC emphasizes that, under the CTR, the follow-up of a pregnant partner should be regarded as part of the original clinical trial and reviewed by the same EC responsible for the main CTR-study.

Because the law of May 7, 2004, on experiments on the human person, is applicable to the follow-up of the pregnant partner, this also implies that Article 29 of this law (liability and insurance) applies. Therefore, a compliant insurance clause should be included in the ICF for the pregnant partner. Participation of the pregnant partner in this observational study is voluntary. A thorough and adequate
Pregnant partner ICF is required. It is acceptable if this ICF is submitted via an amendment when this exceptional situation arises.

A separate ICF for the child (“infant authorization”) can be prepared if data on the child’s health status concerning the drug’s safety will be collected once the child is born but it is also possible and preferable to include this follow-up in the Pregnant partner ICF. It is recommended to secure two signatures on the ICF for continued follow-up of the child.

There may also be additional requirements for the pregnant partner beyond simply collecting their data, such as completing questionnaires or participating in phone contacts. In that case, it qualifies as an interventional study. This means that a separate ICF is definitely needed to properly inform the partner and obtain consent for their participation in the interventional aspects of the study.

Justification follow-up

The necessity of conducting follow-up, particularly of the pregnant participant, pregnant partner, or child, should take into account e.g. the available preclinical and clinical data regarding drug exposure during pregnancy, known effects of similar substances on pregnancy or fetal development and the pharmacokinetics of the investigational drug, especially its half-life. The drug’s half-life will determine
how long the substance remains active within the body and its potential to cause long-term effects. However, in case (pre)clinical data show the investigational drug or its metabolites binding covalently
to the target, the pharmacokinetic half-life is likely to underestimate the duration of action and the pharmacokinetics cannot be used as surrogate for the duration of the pharmacodynamic effects.

If the drug or any metabolites have a short half-life, meaning it is rapidly cleared from the system, the need for prolonged follow-up may be reduced. In such cases, a more limited or shorter follow-up period could be justified, especially if there is no evidence suggesting long-term residual effects of the drug on pregnancy or fetal development.

When determining the follow-up strategy, the study protocol should outline a clear rationale, supported by pharmacokinetics.

Harmonisation of fees

Written by Editor on . Posted in Advice, Financials.

BAREC has standardized certain fees that are not legally required. This helps optimize processes and ensures greater clarity. Regularly reviewing the updated rates is essential to ensure they stay aligned with rising costs and administrative demands.

Based on the feedback received from our members, the BAREC Board has decided on the following amounts:

1. Biobank Recognition:

The initial recognition fee and bi-annual reassessment fee is increased to €2000. This better aligns with the administrative costs and efforts involved in the biobank evaluation process and the required bi-annual report submission to the EC.

2. Retrospective Commercial Studies:

The initial fee for retrospective commercial studies is set at €670.68 (in 2026). This fee is based on the fee for a non-interventional experiment.
The amendment fee will be €167.69 (in 2026).

3. Commercial studies on secondary use of HBM (Human Body Material):

We refer to the above fees for retrospective studies when applying the same rates to commercial studies involving human biological material, ensuring consistency across different study types.

4. Non-Study Specific Recruitment Materials:

A €500 fee for reviewing non-study-specific recruitment materials is appropriate, covering the time and resources needed for evaluation.

Compensation contraception

Written by Editor on . Posted in Compensation.

BAREC wishes to provide clear guidance on the reimbursement of contraception-related expenses in the context of clinical trials, emphasizing the principle that sponsors should cover these costs when a participant is required to use contraception as part of the study protocol.

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