cover letter template ctis

EudraLex - Volume 10 - Clinical trials guidelines

Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.

A number of documents in Volume 10 have been revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014. Additionally, new documents were prepared to cover new aspects introduced by the same Regulation.

In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014, these documents are listed in two separate pages on the Eudralex Volume 10 website.

During the transitional period, which will last until 30 January 2025, both sets of documents will apply accordingly and should be referred to respectively according to the legislation under which the Clinical trial is conducted.

At the end of the transitional period all clinical trials shall be conducted under the Regulation and should follow only the set of documents applicable to the Regulation.

• Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

Set of documents applicable to clinical trials authorised under Regulation EU No 536/2014

• Quick guide for sponsors - Regulation 536/2014 in practice
• Questions and Answers Document - Regulation (EU) 536/2014 Annex II of the Q&A provides the language requirements for part I documents. Annex III of the Q&A provides lists of Member States websites specifying national requirements and contact details for Part I and Part II application

Chapter I - Application and application documents

• Template statement on compliance Regulation (EU) 2016/679: PDF / Word
• Compensation for trial participants - Template: PDF / Word
• Harmonisation guidance: PDF
• Investigator Curriculum Vitae template: PDF / Word
• Declaration of interest template: PDF / Word
• Site suitability form: PDF / Word
• Informed consent and patient recruitment procedure template: PDF / Word
• Compliance with applicable rules for biological samples: PDF / Word

Chapter II - Safety reporting

• ICH guideline E2F - Note for guidance on development safety update reports (September 2010)

For more guidance on safety reporting please refer to the Q&A document on the Clinical Trials Regulation in Chapter V

Chapter III – Quality

• Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice
• Template for the qualified person's declaration equivalence to EU GMP for Investigational Medicinal Products manufactured in third countries : PDF version - Word version (may 2013)
• Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014
• Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
• Union Basic Format for Manufacturer's Authorisation (June 2013)
• Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (revision 2  – January 2022)
• Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (Revision 2 - January 2022)
• Auxiliary medicinal products in clinical trials (rev. 3, March 2024)

Chapter IV – Inspections

• Guidance for the conduct of good clinical practice inspections (August 2017)
• Annex I – to guidance for the conduct of good clinical practice inspections – investigator site (September 2017)
• Annex II – to guidance for the conduct of good clinical practice inspections – clinical laboratories (August 2017)
• Annex III – to guidance for the conduct of good clinical practice inspections – computer systems (September 2023)
• Annex IV – to guidance for the conduct of good clinical practice inspections – sponsor and CRO (August 2017)
• Annex VI – to guidance for the conduct of good clinical practice inspections – record keeping and archiving of documents (June 2017)
• Annex VII – to guidance for the conduct of good clinical practice inspections – bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (June 2017)
• Guidance for the preparation of good clinical practice inspections (August 2017)
• Guidance for the preparation of GCP inspection reports and communication of inspection findings (February 2022)
• Guidance for coordination of GCP inspections requested in the context of marketing authorisation applications for mutual recognition and decentralised procedures and cooperation between Member States (March 2018)
• Annex V – to guidance for the conduct of good clinical practice inspections – Phase I unit (November 2022)

Chapter V - Additional documents

• Guideline on reporting serious breaches
• Appendix III b – Information to be submitted with a notification of a serious breach
• Accelerating clinical trials in the EU (ACT EU) - Delivering an EU clinical trials transformation initiative
• Q&A on Complex clinical trials (May 2022) This document has been developed in close collaboration between the European Medicines Agency, the  Clinical Trials Coordination Group and the Clinical Trial Expert Group. It was endorsed by those groups and by the ACT EU Steering Group.
• Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) This document has been developed and endorsed by the Medical Device Coordination Group (MDCG) and the Clinical Trial Expert Group (CTEG).
• Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation (April 2019) This document is applicable under the Clinical Trials Regulation except for question 11 which explains the current situation under the Clinical Trials Directive.
• Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - EMEA/CHMP/SWP/28367/07 Rev. 1 (July 2017)
• Guideline for good clinical practice - ICH E6(R2) - EMA/CHMP/ICH/135/1995 (2016)
• Risk proportionate approaches in clinical trials (April 2017)
• Summaries of Clinical Trial Results for Laypersons (version 2 - February 2018)
• Good Lay Summary Practice Guidance
• Ethical considerations for clinical trials on medicinal products conducted with minors
• Guideline on the content, management and archiving of the clinical trial master file
• List of national contact points

Chapter VI – Legislation

Commission Delegated Regulation (EU) 2022/2239 of 6 September 2022 amending Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards labelling requirements for unauthorised investigational and unauthorised auxiliary medicinal products for human use

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

Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council

Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here ) of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

Set of documents applicable to clinical trials authorised under Directive 2001/20/EC

Joint EC/EMA/HMA technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU

General information (July 2006)

Chapter I - Application and application form

• Annex 1 revised : PDF version - Word version (revision 4 of November 2009 ; updated on 22 of November 2019). EudraCT Version 8.0 uses the Revision 4 dated November 2009 of the Clinical Trials Application Form (updated on November 22, 2019). For more information please refer to the EudraCT website .
• Substantial Amendment Notification Form : PDF version - Word version (revision 3 of June 2010)
• Declaration of the End of Trial Form : PDF version - Word version (revision 19 of June 2019)
• Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use (revision 1 of February 2006)
• Detailed guidance on the European clinical trials database (EUDRACT Database) (revision of April 2004)
• Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ("CT-3")

Chapter III - Quality of the investigational medicinal product

• Good manufacturing practices for manufacture of investigational medicinal products (February 2010)
• Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014 (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
• Union Basic Format for Manufacturer's Authorisation (October 2014)
• Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
• Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (September 2018)
• Guidance on Investigational Medicinal Products (IMPs) and "non investigational medicinal products" (NIMPs) (rev. 1, March 2011)

Chapter IV - Inspections

• Guidance for the preparation of GCP inspections (June 2008)
• Recommendation on inspection procedures for the verification of good clinical practice compliance (July 2006)
• Guidance for the conduct of GCP inspections (June 2008)
• Annex I to Guidance for the conduct of GCP inspections - Investigator site (June 2008)
• Annex II to Guidance for the conduct of GCP inspection - Clinical laboratories (June 2008)
• Annex III to Guidance for the conduct of GCP inspections - Computer systems (June 2008)
• Annex IV to Guidance for the conduct of GCP inspections - Sponsor and CRO (June 2008)
• Annex V to Guidance for the conduct of GCP inspections - Phase I Units (November 2008)
• Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents (March 2010)
• Annex VII to Guidance for the conduct of GCP inspections - Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials (November 2008)
• Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h), in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures (June 2009)
• Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC (revision 1 - May 2009)
• Guidance for the communication on GCP inspections and findings (June 2008)
• Procedure for standardisation of GCP inspection entries in EudraCT (November 2008)
• Guidance for the preparation of Good Clinical Practice inspection reports (June 2008)
• Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice (July 2006)

Chapter V - Additional information

• Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (2019)
• "Questions & Answers" Document - Version 11.0 (May 2013)
• Original version (2008)
• Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products
• List of fields contained in the "EudraCT" clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02 (June 2019)
• Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMA), in accordance with Article 41 of Regulation (EC) No 1901/2006
• List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01 (June 2019)
• Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
• Technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 (January 2013)
• EudraCT - List of additional fields contained in EudraCT (reasons for negative opinions of the Ethics Committee) (November 2010)

Chapter VI - Legislation

• Directive 2001/20/EC OF the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
• Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22-26)

Latest updates

• News announcement
• 12 September 2024
• 28 August 2024
• 9 August 2024
• 2 August 2024

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Clinical Trials Information System – CTIS

Message to sponsors transitioning clinical trials from ctd to ctr/ctis.

Clinical trials (CTs) authorised under the Clinical Trials Directive 2001/20/EC ( CTD ) likely to be ongoing beyond 30 January 2025 need to be transitioned to the Clinical Trials Regulation 536/214 (CTR). Details of the requirements for transitioning CTs are provided in the European Commission’s Guidance for the transition of clinical trials . Further ‘Best practice’ information and the required cover letter including annex template can be found at the homepage of the Clinical Trial Coordination Group , CTCG, unter key documents. For transitioning part II, please take care of the information by the Association of Medical Ethics Committees in Germany ( AKEK ).

The transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation is open to sponsors until the end of the 3-year transitional period, on 30 January 2025, without the need to discontinue a clinical trial or put a trial on hold. Clinical Trials transitioned need to be authorized by that date. Thereafter, an initial CT application of the ongoing CT will be necessary.

Sponsors should, however, take into account the time necessary for completion of the authorisation procedure under Chapter 2 of the CTR and the European Commission’s guidance . Therefore, sponsors are strongly advised to submit their applications prior to 30 January 2025 taking into account the assessment time, which can extend from 1 week (expedited process) to up to 106 days in case a full trial application is needed, also be aware of the winter clock stop between 22 December and 6 January.

By late October 2023, only around 390 transitional trials have been submitted to CTIS out of an estimated 4,000 - 6,000 trials pending to be transitioned by 30 January 2025.

Further resources and guidance from the European Medicines Regulatory Network are available on the CTIS website under the section “Transitioning Trials”) in order to support sponsors transitioning their trials to the CTR/CTIS.

Clinical Trials Regulation and CTIS

The manner clinical trials are conducted in the European Union ( EU ) has changed significantly since the Clinical Trials Regulation (Regulation ( EU ) No. 536/2014) came into force on 31 January 2022 . The Regulation harmonises the submission, assessment and supervision processes for clinical trials in the EU through the Clinical Trials Information System ( CTIS ).

CTIS will be the single entry point for submitting clinical trial information in the EU and the European Economic Area ( EEA ). CTIS will contain a Sponsor workspace for clinical trial sponsors and the organisations that work with them, an Authority workspace for EU Member States, EEA countries and the European Commission, and a public website.

• The Sponsor secure workspace will assist clinical trial sponsors in preparing and compiling the clinical trial application and related documents to submit for assessment.
• The Authority secure workspace will support the activities of EU Member States, EEA countries and the European Commission in assessing and overseeing clinical trials.
• Through the public website, members of the public can access detailed information on all clinical trials conducted in the EU and the EEA once trials start to be submitted and approved in CTIS .

EU Member States and EEA countries will assess and supervise clinical trials in CTIS , while EMA sets up and maintains CTIS . The European Commission ensures the correct interpretation and implementation of the Clinical Trials Regulation.

Transition period

The Clinical Trials Regulation foresees a 3-year transition period to CTIS .

• From 31 January 2022 until 31 January 2023, clinical trial sponsors can choose to submit their clinical trial applications under the Clinical Trials Directive ( EG ) No. 2001/20/EC through national submission processes, or under the Clinical Trials Regulation through CTIS .
• From 31 January 2023 all new clinical trial applications in the EU and EEA must be submitted under the Clinical Trials Regulation through CTIS .
• From 31 January 2025 trials approved under the Clinical Trials Directive that are still ongoing will have to be transferred to the Clinical Trials Regulation and to CTIS .

EU Member States and EEA countries will have to work in CTIS from go-live, once applications are submitted.

How clinical trials will be processed in CTIS ?

Clinical trial sponsors who want to gain regulatory approval for a clinical trial in one or more EU Member States and EEA countries will submit a single clinical trial application form and supporting dossier through CTIS . The submission of the single clinical trials application form and supporting dossier will also include the public registration of the clinical trial.

CTIS will support the day-to-day business processes of EU Member States, EEA countries and sponsors throughout the lifecycle of a clinical trial. It will provide regulatory oversight of clinical trials and tools for supervision and monitoring.

How to register for CTIS ?

Before using CTIS , users must have an EMA account. Users that have already an EMA account, for example to use Eudravigilance or the substances, products, organisations and referentials database ( SPOR ) do not need to create a new account. Users that do not have an EMA account can register via EMA Account Management .

Organisations may need to complete additional registration steps based on the user management approach they choose for CTIS . The organisation-centric approach allows for the management of users by an administrator at the organisation level rather than at the level of an individual trial. It is intended for organisations that will run several trials in CTIS . To make use of the organisation-centric approach, organisations must ensure they are registered in EMA’s Organisation Management System ( OMS ), and they must register a CTIS High Level Administrator via EMA Account Management .

Uploading of requested or revised documents in the context of validation or assessment.

If further, corrected or updated documents as part of the application have been requested as further information (RFI), the sponsor must upload them under the originally submitted document files. Uploading the documents as a direct response to the RFI in CTIS in the response area of the corresponding "Consideration" is not acceptable. Otherwise, these documents would no longer appear in the CTIS overview of uploaded documents as part of this application (initial application, substantial modification...) in the latest, most up-to-date version.

Are there shortened deadlines for mononational clinical trials?

Validated clinical trial applications for mononational clinical trials are assessed within 26 days at BfArM . In case of no deficiencies the final trial authorisation is granted within 31 days at the latest. The Working Group of the German Medical Ethics Committees (Arbeitskreis Medizinischer Ethik-Kommissionen, AKEK ) agreed to follow these timelines as well. 

Are there shortened deadlines for phase I studies?

Mononational phase I studies are assessed within 26 days after successful validation. Should the application be free of defects, a decision can be made by day 31. This also applies to other mononational studies of other phases.

Should it be a mononational and monocentric study, it will be examined on a case-by-case basis whether a shortening of the validation phase is also possible.

How to prepare for CTIS ?

Sponsors can consult the CTIS Sponsor Handbook for guidance on how to prepare for CTIS .

In addition, sponsors can use the CTIS online training programme. The guide to the CTIS training material catalogue, which can be found on the training programme page on the EMA website, provides an overview of the training programme,

Further Informationen

• For more information on CTIS , visit the following page on the EMA Website: Clinical Trials Regulation and CTIS .
• For more information on training and support for the use of CTIS , visit the CTIS training and support page on the EMA website: CTIS training and support .
• For information and training on the functionalities of CTIS , visit the following page on the EMA website: CTIS online modular training programme .
• CTIS Sponsor Handbook: Handbook for clinical trial sponsors .
• CTIS Newsletter: Clinical Trials Information System ( CTIS ) highlight s
• For information on the Clinical Trials Regulation, see: EudraLex - Volume 10 - Clinical trials guidelines
• Questions on CTIS functionalities can be directed through the CTIS User Support Service.
• Article in EUobserver, July 19, 2024 - Clinical trials data publication now more transparent in the EU

CTIS for sponsors

The sponsor workspace in the Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organisations involved in running clinical trials in preparing and compiling clinical trial applications and dossiers to submit for assessment by Member States in the European Union (EU) and European Economic Area (EEA).

The revised CTIS transparency rules will become applicable on 18 June 2024, with the launch of a new version of the CTIS website. Support materials and more information are available under Transparency: Questions and Answers .

Target CTIS sponsor workspace users

• Clinical trial sponsors
• Marketing authorisation applicants and holders
• Other organisations involved in running clinical trials

Functionalities

• Manage registered users and user roles
• Compile clinical trial applications for new and updated or ongoing trials
• Cross-reference to product documents in other clinical trials
• Submit clinical trial applications and updates for assessment by Member States
• Receive alerts and notifications for ongoing trials
• Respond to requests for information and view deadlines
• Search and access clinical trials
• Issue notifications related to key milestones in the trial lifecycle (e.g. start of recruitment, end of recruitment)
• Record clinical trial results

Getting started

Log in to the sponsor workspace using your EMA account . If you have access to any EMA-hosted websites or online applications requiring registration, you already have an EMA account and you should use the same credentials.

How to register

If you do not have an EMA account , you need to create an EMA account first. See EMA's training materials for more information on how to obtain user roles.

New to CTIS?   You need to choose a user management approach and may need to register your organisation. You may also need to register your investigational medicine. Find out more

Training materials

Training and supporting materials are available for sponsors on how to use the Clinical Trials Information System sponsor secure workspace.

Find questions and answers on how to use CTIS.

If you cannot find an answer to your question in the guidance and Q&As, please contact the User support service.

See when this website and CTIS will be unavailable due to maintenance and upgrades, as well as an overview of system releases.

EMA news and events

Find EMA news and events related to clinical trials in the EU and the EEA.

Related legislation and guidance

• Clinical Trials Regulation (Regulation (EU) No 536/2014)
• Eudralex - Volume 10 – clinical trials guidelines
• Questions and answers document on the Clinical Trials Regulation
• Information EMA on clinical trials in human medicines
• Guidance Clinical Trials Coordination Group (CTCG)

Related services and databases

• EMA Account Management portal
• EudraVigilance
• European Union Drug Regulating Authorities Clinical Trials (EudraCT) database
• EU Clinical Trials Register
• Extended EudraVigilance medicinal product dictionary (XEVMPD) training

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Sales Assistant Cover Letter with No Experience Sample

Writing a cover letter when you have no experience can feel intimidating. However, as someone who has helped numerous friends and clients craft unique sales assistant cover letters without any previous experience, I’ve developed a method that not only works but also makes you stand out from the crowd. 

In this guide, I’ll share my personal approach to writing a sales assistant cover letter with no experience, provide three unique templates, and offer real-life tips to help you succeed.

Sales Assistant Cover Letter Generator

Disclaimer: This is a basic cover letter generator to help you draft a sales assistant cover letter. Please ensure you review and customize it to match your specific experience and job application.

Key Takeaways:

• What you’ll learn : How to craft a sales assistant cover letter without prior experience.
• How do I write a sales assistant cover letter with no experience?
• What should I focus on to impress hiring managers?
• Are there templates I can use to make the process easier?
• Focus on transferable skills like communication and teamwork.
• Show enthusiasm for sales and customer service.
• Customize your letter to match the job description.

Why Your Cover Letter Matters

From personal experience, I can confidently say that a well-crafted cover letter can make all the difference. While a resume lists qualifications, the cover letter gives you the chance to express who you are. 

For sales assistant positions, this is vital, especially if you lack direct experience. Many of my clients who were fresh out of school or switching careers used cover letters to land their first job in retail sales by focusing on their skills and enthusiasm.

Step-by-Step Guide to Writing a Sales Assistant Cover Letter with No Experience

1. focus on transferable skills.

You may not have experience in sales, but you probably have skills that can easily transfer. For example, customer service, teamwork, and communication are all key traits employers look for in sales assistants. In my work helping clients, I’ve found that highlighting experiences from volunteering, school projects, or part-time jobs goes a long way.

2. Show Enthusiasm for the Role

One common mistake I see is cover letters that are too generic. A sales assistant role requires energy, enthusiasm, and a passion for helping customers. Show the hiring manager that you’re excited about working in retail and that you understand the importance of customer satisfaction.

3. Tailor Your Cover Letter to the Job

While templates are helpful (and I’ll provide you with three), make sure to customize each cover letter to the specific job you’re applying for. Mention the company by name and reference the job description to show that you’ve done your research.

Here’s a list of key areas to focus on:

Template 1: Simple and Straightforward

Dear [Hiring Manager’s Name],

I am writing to express my interest in the Sales Assistant position at [Company Name]. While I do not have direct experience in sales, I believe my strong communication skills, attention to detail, and passion for customer service make me an excellent candidate for this role.

In my previous roles as a volunteer and through school projects, I’ve developed valuable skills such as teamwork, problem-solving, and providing excellent customer support. I am confident that my enthusiasm for learning and my ability to quickly adapt to new environments will allow me to contribute positively to your team.

I am excited about the opportunity to work at [Company Name] and would welcome the chance to discuss how my skills can benefit your company. Thank you for your time and consideration.

Sincerely, [Your Name]

Template 2: Skill-Based Approach

I am reaching out to apply for the Sales Assistant position at [Company Name]. Although I do not have formal sales experience, my background in customer service has provided me with strong interpersonal and communication skills that I believe would be valuable in this role.

For instance, during my time working in a fast-paced café, I learned how to efficiently handle multiple tasks while ensuring customer satisfaction. I believe that my ability to connect with people and solve problems will allow me to thrive as a sales assistant.

I would be thrilled to join your team and am eager to learn and grow within the retail industry. I appreciate your time and consideration and look forward to the opportunity to speak further.

Best regards, [Your Name]

Template 3: Enthusiastic and Eager to Learn

I am excited to apply for the Sales Assistant position at [Company Name]. While I am new to the sales industry, I am eager to learn and develop the necessary skills to excel in this field. I am particularly drawn to the dynamic, customer-focused environment of your store and would love the opportunity to contribute.

My past experiences have taught me the value of communication and teamwork. As a student volunteer, I frequently worked with diverse groups of people, helping me to become a flexible and adaptive team player. I am confident that my enthusiasm and willingness to learn will make me a valuable asset to your team.

Thank you for considering my application. I look forward to the opportunity to further discuss how I can contribute to your sales team.

Warm regards, [Your Name]

Tips from Personal Experience

Here are a few tips I’ve gathered over the years that have helped my clients land interviews even with no prior sales experience:

Be Confident : Just because you lack experience doesn’t mean you lack value. Employers appreciate candidates who are confident in their abilities and willing to learn.

Use Real-Life Examples : If you have any examples of dealing with people, even outside of work, use them. For example, organizing events, managing school projects, or volunteering at community activities can showcase your ability to work with others.

Follow Up : After sending your cover letter, follow up within a week. This shows that you’re genuinely interested in the position.

Final Thoughts

Writing a sales assistant cover letter with no experience can seem challenging, but with the right approach, you can make a powerful impression. Through focusing on transferable skills, showing enthusiasm for the role, and tailoring your cover letter to the company, you will stand out from other applicants. 

Frequently Asked Questions (FAQs)

Q: how do i write a sales assistant cover letter with no experience.

Answer: From my experience, focus on your transferable skills like communication and teamwork, and show enthusiasm for the role. Tailor the letter to the specific company and explain how you’re eager to learn and grow in the sales industry.

Q: What skills should I highlight in a sales assistant cover letter with no experience?

Answer: Highlight skills like customer service, problem-solving, teamwork, and communication, which are crucial in retail. These are all transferable skills that I’ve seen work for others who were new to sales roles.

Q: How long should a sales assistant cover letter with no experience be?

Answer: In my experience, keep your cover letter concise and to the point—no more than one page. Focus on explaining why you’re the right fit for the job and how your skills can benefit the company.

Q: Can I still apply for a sales assistant job if I have no experience?

Answer: Absolutely! I’ve helped many clients land sales assistant jobs without experience by crafting cover letters that highlight their enthusiasm and transferable skills like customer service and communication.

Q: What should the introduction include in a sales assistant cover letter with no experience?

Answer: The introduction should express your excitement for the position and briefly mention your relevant skills. I always recommend mentioning the company name to show that you’ve done your research and are genuinely interested.

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Questions and answers CTR – The Netherlands

Below you will find questions and answers on the Clinical Trials Regulation (CTR) specific for the situation in the Netherlands.

Contact details

Where can i ask questions about the assessment of clinical trials with medicinal products in the netherlands.

For questions about the assessment of clinical trials with medicinal products in the Netherlands, please email: [email protected] .

Where can I ask questions about the submission of clinical trials with medicinal products in the Netherlands, if the University Medical Centre (UMC) is the sponsor?

In that case, you may contact the representative for clinical trials in the relevant UMC. The email addresses for questions on clinical trials with medicinal products of the seven UMCs in the Netherlands are listed below.

Application dossier

Will the abr and eudract form disappear for clinical trials after 31 january 2022.

For clinical trials submitted via CTIS according to the rules of the CTR, the ABR form and EudraCT form expire. For currently ongoing clinical trials, the ABR form and EudraCT form will continue to exist as long as these studies have not been transferred to CTIS. See our website for more information about the transition period .

For studies submitted in EudraCT, and not yet transferred to CTIS, a Frequently Asked Questions document is available. It also contains information about the transition to CTIS as of 31 January 2025. See the frequently asked questions about EudraCT on the European Medicines Agency website.

Does the clinical trial agreement (CTA) have to be submitted?

No, the CTR does not provide for this. In order to be able to continue to ensure that the agreements with regard to the publication and termination of the clinical trial are in accordance with the Richtlijn Beoordeling Onderzoekscontracten (CCMO Directive on the assessment of clinical trial agreements), questions on these two matters have been included in the form 'Compensation for trial participants, investigator, funding clinical trial and other arrangements' (research dossier Part II). This form can be found on Financial and other arrangements .

Is the independent expert still mandatory? The CV is no longer part of the dossier.

No, an independent expert is no longer required under the CTR.

Are the CCMO templates mandatory or can similar templates be used from, for example, the sponsor?

The CCMO templates are mandatory with the exception of the template CV of the investigator.

Do documents such as CV and VGO have to be submitted with a signature? And if so, can this be an electronic signature?

In the Netherlands the CV may be submitted without a signature in CTIS. This does not apply to the Site Suitability Declaration ( Verklaring Geschiktheid Onderzoeksinstelling , VGO). A validated digital signature is accepted for this document. A signature is considered personal data. Any document with a signature and to be published based on the transparency rules for CTIS should be redacted (see: Redacted and unredacted documents ).

In October 2023 EMA published revised transparency rules for CTIS (see: Transparency rules: general information) . Based on these revised transparency rules, CV and VGO will not be published in the public portal of CTIS. As long as the revised rules are not technically implemented in CTIS, the sponsor is allowed to upload a document in the slot “for publication” with the text “The present document is no longer subject to publication in line with revised CTIS transparency rules. Further information is provided in section 4 of the ‘Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS’ published on the ACT EU website – Implementation of the Clinical Trials Regulation” (see also annex I of the Q&A on the revised transparency rules in CTIS). In the slot “not for publication”, the sponsor shall upload the documents with signatures.

Do patient facing documents, such as questionnaires, diaries, etc., have to submitted in CTIS?

Documents, such as questionnaires and diaries, used to record study endpoints must be described in the study protocol and can be added as annexes to the protocol. Validated standard questionnaires, such as the quality of life questionnaire SF36, do not need to be included. See also the page on the protocol .

Is a VGO required for a new site that will be added to a study that has been submitted before 1 November 2021?

For clinical trials submitted before 1 November 2021, the Research Declaration ( Onderzoeksverklaring ) can be used for the new sites. The use of the Site Suitability Declaration ( Verklaring Geschiktheid Onderzoeksinstelling , VGO) is voluntary for studies submitted before 1 November 2021.

Should the full EU Clinical Trial number be included in all documents?

No, it is enough to mention the EU Clinical Trial number without the last two digits in the documents. The last two digits refer to whether it concerns a first submission (EU clinical trial number ends with -00) or a re-submission of the same dossier (EU clinical trial number ends with -01 or higher). By leaving these last two digits out in the documents, the EU clinical trial number in the documents do not have to be changed when re-submission is required.

Is it possible to register more sites in CTIS in advance, to take into account the possibility that a site will not start, or will not include patients?

Only the centers for which the set of documents is complete should be submitted in CTIS. This means a signed VGO, a CV and a declaration of interests of the principal investigator.

Does every affiliate have to be registered in OMS, or just the (main) sponsor location?

Each affiliate must be registered separately in the OMS system and receives an unique ID. The OMS distinguishes between Organization IDs and Location IDs, where Organizations are country specific and locations under an Organization are located in that same country. For each country you create an Organization with Location (s). For more information, see the document on EMA's website .

When the sponsor is located outside the EU, it is mandatory to have a legal representative in an EU country. Does the legal representative also have to be registered in OMS?

The organizations that need to be registered in OMS to be available for CTIS are sponsors or co-sponsors, third party contractors (e.g. CRO), EEA trial sites, and Marketing Authorisation Holders.

Product registration

Does registration of products in the eudravigilance product database only apply to the imp, or also to the active substance of the imp.

The EudraVigilance product database (XEVPMD) applies to medicines authorised in the EU (AMPs) and to IMPs used in clinical trials. The active substances have to be registered as well. See also paragraph 5 (Product management in CTIS) of the Sponsor Handbook . See for more detailed information the document on EMA's website .

Can participating sites in a country be added during the initial assessment?

No. The addition of a new participating center is a substantial amendment (of Part II). A substantial part II amendment can only be submitted in a Member State if:

• the Member State concerned has issued a positive decision on the clinical trial, and
• no other substantial amendment to the same clinical trial is being assessed in the Member State concerned.

For more information on substantial modifications, see Submission of a substantial modification .

Will the marginal review by the competent authority continue to exist with a CTIS submission?

No, the marginal review by the competent authority (CCMO or Ministry of Health, Welfare and Sport) shall be repealed for clinical trials submitted in CTIS.

Safety reporting

How should susars and annual safety reports be reported to the mrecs in the netherlands.

For CTR clinical trials all SUSARs must be reported via Eudravigilance. This means that every sponsor of a clinical trial must have access to EudraVigilance or must apply to the EMA for such an access. If a sponsor does not have the possibility to report SUSARs in Eudravigilance due to a lack of resources, the CCMO can be contacted. The annual safety report (ASR/DSUR) must be submitted in CTIS.

For CTD clinical trials all SUSARs must also be reported via Eudravigilance. If a sponsor does not have the possibility to report SUSARs via Eudraviglance, he can report this in the SUSAR module of ToetsingOnline. The competent authority will report SUSARs occurring in the Netherlands in Eudraviglance. In addition, the obligation to report all SUSARs to the MREC remains. SUSARs no longer need to be reported to the competent authority. However, the annual safety report (ASR/DSUR) has to be submitted to the MREC and to the competent authority.

Do SAEs still have to be reported (separately)?

This is the same as under the old legislation (Directive 2001/20/EC (CTD)). The investigator must report the SAE to the sponsor within 24 hours of it being discovered. The protocol defines the type of SAE that does not require immediate notification. The sponsor shall include an aggregated table of SAEs in the Annual Safety Report (ASR) to be submitted in CTIS. Individual SAEs are not reported in CTIS. If a SAE is suspected to be related to the IMP and is not described in the Reference Safety Information, the SAE should be reported as a SUSAR. SUSARs must be submitted via Eudravigilance.

Are there any plans to include a SUSAR module in CTIS in order to have everything in 1 system?

No, SUSARs always have to be submitted to Eudravigilance.

Transition period

When and how should a clinical trial transition to ctr and what is important after the clinical trial has been transitioned.

All relevant information on so-called ‘transition trials’, clinical trials authorised under the Clinical Trials Directive (CTD) that need to be transitioned to the Clinical Trials Regulation (CTR), can be found on the following CCMO webpage: Transition trials: CTD to CTR .

Trial registry

Is the public part of ctis a registry recognized by who.

The CTIS public portal is not (yet) a WHO primary registry. However, it does meet the requirements for prospective registration set by the International Committee of Medical Journal Editors (ICMJE) for publication in scientific journals.

Currently, CTIS is an official data provider to the International Clinical Trial Registry Platform (ICTRP) of the World Health Organization (WHO). It is EMA’s intention that the CTIS public portal will be a WHO registry, but this application is not yet finalized.   

Is there a connection between CTIS and ClinTrial.gov?

No, CTIS is specifically for the submission and assessment of clinical trials conducted in the European Union.

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Schengen Visa Application Cover Letter – Sample Letter for Schengen Tourist Visa

The cover letter you must submit for your Schengen Visa application is an important document that states the reason you are traveling to a certain Schengen country. In your Schengen Visa Application Cover Letter, you must address the Embassy or Consulate of the destination country you plan to visit, as your main goal is to persuade the Consular staff that you are a suitable candidate for receiving the Schengen visa.

How to Write a Cover Letter for a Schengen Tourist Visa?

Your Schengen tourist visa application cover letter should include the information listed below:

• Your full name.
• Your date of birth.
• Your nationality.
• Your passport details (passport number, issue date, and expiry date).
• Your current address.
• Your email address.
• Your phone number.
• The date when you are writing the letter.
• The name of the embassy or consulate where you are applying for the Schengen visa.
• The embassy or consulate’s address.
• The intention of traveling with a Schengen Tourist Visa (e.g., tourism, sightseeing, visiting friends or family, attending an event, etc.).
• The entry and exit dates of your trip.
• A detailed itinerary of your trip, including the Schengen countries you plan to visit during your trip, information about your planned accommodations, flights, and any tours or activities you have booked.
• Your financial capacity to cover your trip expenses.

Tourist Visa Application Cover Letter Sample