Guideline on Site Organisation Management: How a Site Staff Member Joins a Clinical Trial Team

Finding a research nurse, data coordinator or site management professional for a clinical trial site in Türkiye is not always easy; at small and medium-sized sites, the principal investigator often carries most of the administrative load alone. TİTCK's "Guideline on the Principles of Site Organisation Management in Clinical Trials", dated 13 November 2015, steps in exactly here: it allows the coordinator or principal investigator to include a qualified person from a contract research organisation (CRO) in the trial team as a site staff member for site organisation management services — under strict rules. This article walks through the entire guideline, from the annexed form templates to the notification flow and the nineteen duties of the site staff member.

The full text and the English translation of the guideline are available in our legislation library, also downloadable as PDF.

What does the guideline govern? Two distinct services

Rather than a single regulation, the guideline governs two complementary services — keeping them apart is the first requirement of compliance:

1. Site organisation management service (site staff member): In clinical trials conducted under the "Regulation on Clinical Trials of Pharmaceuticals and Biological Products", the coordinator or principal investigator may include a qualified person from a contract research organisation in the trial team as a site staff member, under his/her own supervision and oversight, for the purpose of performing site organisation management services at the trial site.
2. Data entry support service (data entry support personnel): In studies under the Guideline on Observational Drug Studies, the coordinator physician or participating physicians may include a qualified person from a contract research organisation as data entry support personnel so that study data can be recorded in the required environment.

In both cases the key principle is the same: these persons work under the supervision and oversight of the investigator (physician), independently of the sponsor, and have no authority whatsoever to alter clinical trial data. The entire guideline is built around protecting this principle of independence.

One framing note also matters: the guideline dates from 2015 and the principal regulation it cites has since been replaced by the "Regulation on Clinical Trials of Human Medicinal Products" (Official Gazette 27.05.2023/32203); the guideline nonetheless remains on TİTCK's legislation list, and site staff assignments continue to be carried out within this framework.

Who is a site staff member, and under what conditions?

Article 3 of the guideline sets out the general conditions. They read like a checklist:

• Site personnel are preferred (3.1): The person to be included as a site staff member should preferably be a member of staff of the trial site or institution. This is the guideline's softest yet most meaningful clause: institutional affiliation makes both oversight and continuity easier.
• Request letter for external personnel (3.2): If the person is not site or institution staff, the principal investigator may request one from the contract research organisation independently of the sponsor, documented with a site staff request letter (the template is Annex-1 of the guideline).
• Educational preference (3.3): Persons to be assigned as site staff members should preferably be graduates of health or science disciplines.
• Authorisation is mandatory (3.5): A site staff member who is an employee of a contract research organisation must be authorised by that organisation (intra-company authorisation document — Annex-2, and acceptance of duty — Annex-3).
• Concurrent assignment ban (3.4 and 4.4.1): A site staff member employed by a contract research organisation may not serve at the same time in trials with different sponsors. The exception rests with TİTCK: if the Agency deems it appropriate and the applicant justifies it, the assignment is possible — and the sponsor must be informed.
• The five-investigator limit (3.6): Site staff members may support a maximum of five different principal investigators. Taking into account the nature of the study and the number of participating volunteers, assignments for more investigators are also possible — this is where the guideline allows scale.
• Six-monthly monitoring report (3.7): Following the site staff member's first project assignment, the contract research organisation must submit to TİTCK a monitoring activity report prepared every six months, specific to that site staff member, together with the current status table of site staff projects (Annex-4) (3.8).
• Training obligation (3.9): Site staff members must receive the relevant training on basic good clinical practice (GCP) and on the clinical trial they will join.
• Scope limit (3.10): Under this guideline, a site staff member may serve only in clinical trials covered by the "Regulation on Clinical Trials of Pharmaceuticals and Biological Products".

The notification flow: authorisation, simultaneous notification, start of duty

Article 5 regulates the procedure step by step — mishandling this flow can invalidate the assignment:

1. Application (5.1): Applications are made in line with the application forms and cover letter templates published on the TİTCK website.
2. Dual notification (5.2): The personnel to be assigned is notified by the contract research organisation to both TİTCK and the ethics committee; the notifications may be made simultaneously.
3. Sequence matters (5.2): These notifications are made after the TİTCK authorisation letter has been obtained for the clinical trial to commence. The site staff notification is thus a second administrative step that follows study approval.
4. Power to cancel (5.2): The ethics committee or TİTCK may cancel the assignment with justification.
5. Start of duty (5.2): The relevant person may commence duty at the trial site as of the date of the TİTCK notification.
6. Investigator meetings (5.3): Provided the contract research organisation holds intra-company authorisation documents and TİTCK permission is obtained under the legislation, the person may attend investigators' meetings held before the trial. If the person is a member of staff of the site or institution where the trial is conducted, they may also be included in the trial team in the status of sub-investigator — one of the guideline's most practical doors.

The nineteen duties of a site staff member: a day at the site

The guideline's most detailed section (6.1.1–6.1.19) enumerates the duties one by one. They cluster into five groups:

Volunteer screening and appointment management (6.1.1–6.1.3, 6.1.5): Visiting referral centres and physicians that send patients meeting the trial criteria and reminding them of volunteer screening conditions; where the necessary permissions are obtained and confidentiality principles observed, reviewing hospital files under the principal investigator's supervision to identify suitable volunteers; organising volunteers' appointments and tracking that visits happen on time; assisting the team with non-invasive procedures authorised by the investigator.

Document and traceability management (6.1.4, 6.1.8, 6.1.9, 6.1.11, 6.1.15, 6.1.19): Ensuring the filing of the informed consent forms (ICF) obtained from volunteers and reminding the principal investigator to give the volunteer a copy; assisting with complete records of the procedures performed by physician-investigators and the filing of documents; helping to ensure that volunteer information is completely recorded in hospital source documents; ensuring that study-specific documents such as laboratory results, ECG assessments, IVRS confirmations and scales are reviewed and signed in a timely manner by the physician-investigator and duly filed; placing all correspondence from the sponsor and the ethics committee in the investigator's file; helping establish the environment in which trial files will be stored.

Data management — without alteration (6.1.10, 6.1.16, 6.1.17): Assisting, within the scope of their authority, with the complete entry of volunteer data onto paper or electronic case report forms (e-CRF), files and screening cards without any alteration whatsoever; ensuring data queries are answered in a timely manner by the principal investigator; providing the volunteer information requested by analysis units during interim analysis periods.

Laboratory and material logistics (6.1.7, 6.1.12): Sending blood samples to the central or local laboratory in accordance with the protocol, organising and tracking courier processes; ensuring laboratory reports are reviewed and filed by the physician-investigator, and if a flagged abnormal finding appears, informing the relevant persons so that immediate action is taken; taking measures so that trial materials, patient diaries, laboratory kits and patient identification cards remain in sufficient supply throughout the trial.

Safety and notification flow (6.1.13, 6.1.14, 6.1.18): Ensuring that forms for safety reports matching the definition of a serious adverse event are completed by the physician-investigator and immediately reported to the sponsor, and following up these events (including obtaining discharge summaries, hospital admission records or death reports); carrying out the notification to the ethics committee and TİTCK of all documents that must be reported — investigator's brochure amendments, protocol amendments, investigator notifications — and tracking the decisions; ensuring the letter confirming the end of the trial is submitted to the ethics committee.

Roles and boundaries: investigator, sponsor, contract research organisation

Article 4 draws a clear line between the roles:

• Coordinator / principal investigator: Documents that the sponsor has been informed; only the coordinator or principal investigator may direct the site staff member, and the person to be assigned is submitted to the sponsor for approval. The pivotal undertaking is this: the investigator undertakes that the site staff member acts independently of the sponsor, complies with the task descriptions in the authorisation list, and has no authority whatsoever to alter clinical trial data. Administrative notifications within the investigator's institution, where required, also fall to the investigator.
• Sponsor: Enters into the commercial agreements financing the services — and its limits are clear: apart from financing, the sponsor may train the site staff member only in trial-specific trainings given to the trial team and in basic GCP training; it may not be otherwise involved. It must inform the contract research organisation of trainings in advance and transmit the training records.
• Contract research organisation: Ensures its personnel are not assigned simultaneously to trials with different sponsors; makes the assignment and assignment-termination notifications required by the legislation; ensures and records that its personnel have received GCP and study-specific training; guarantees that the trainings are properly provided; and reports on data entry at regular intervals.

This line summarises the legislative logic of the site staff model in Türkiye: operational support is free; authority over data is zero. Every duty, from volunteer screening to archiving, is performed either under the physician's supervision or organised on their behalf — no duty involves changing the data itself.

The difference in observational studies: data entry support personnel

For studies under the Guideline on Observational Drug Studies, the framework is leaner (3.11–3.14 and 7.1): the coordinator or participating physician may request data entry support personnel independently of the sponsor, with a request letter (Annex-5); each participating physician need not authorise personnel separately. The person is again authorised by the contract research organisation (Annex-6, Annex-7) and must receive basic GCP and study-specific training. The duty list narrows to six items: pre-screening support documented by permissions, checking the suitability of ICFs and data usage permission forms, checking that the permissions required to start the study have been obtained, assisting — under the participating physician's supervision — with transferring visit data to the relevant forms in protocol compliance, supporting data entry onto e-CRFs without alteration, and answering data query forms during interim analyses and sending them to the relevant units.

Entry into force and amendment history

The current guideline is dated 13 November 2015 and repealed the previous "Guideline on the Principles of Site Organisation Management in Clinical Trials" put into effect by the Approval of the Presidency No. 95052 dated 06.08.2014. The guideline's own amendment table also shows the Agency's accumulated practice in this area:

No Date of publication Issue number 1 21.02.2011 1491 2 11.05.2011 4196 3 23.08.2011 7481 4 17.04.2013 43020 5 06.08.2014 95052 — 13.11.2015 Current text

The guideline's seven annexes (Annex-1 to Annex-7) provide templates for the request forms, intra-company authorisation and acceptance of duty documents, and the current status table — the guideline explicitly requires the annexed documents to be on letterhead and a copy of the authorised person's signature circular to be attached.

Practical takeaways

For investigators: The site staff member model is a compliant way to add a human resource that takes over workload — but the guardrails must be fully respected: the preference order (your own staff first), the five-investigator limit, the independence undertaking and the notification timing. Keep the assignment letters and the authorisation chain (request → authorisation → acceptance of duty) ready in your file.

For sponsors and CRO/SMOs: Site staff assignment is the official framework of site organisation management services; the concurrent-assignment ban and the six-monthly monitoring report are inputs to portfolio planning. For teams providing this service under the guideline, the reporting schedule and the status table are among the first documents requested in agency inspections.

For the full picture of clinical trial legislation in Türkiye, see the Türkiye Clinical Trial Regulatory Hub; for full texts, our legislation library; for detailed reviews of the GCP guideline and the ATMP guidelines, read our ATMP guidelines article.

Frequently asked questions

Who requests a site staff member? The coordinator or principal investigator, independently of the sponsor and with a request letter (Annex-1); the assigned person works under the investigator's supervision and oversight. The assignment is submitted to the sponsor for approval.

How many investigators can a site staff member support? At most five different principal investigators under the guideline; assignments for more are possible when circumstances such as the nature of the study and the number of volunteers warrant it.

Can a site staff member serve in several trials at once? Not in trials with different sponsors; an exception is possible if TİTCK deems it appropriate and the applicant justifies it, and the situation is notified to the sponsor.

Can a site staff member do data entry? Yes — but only as an assistant and without any alteration: within their authority and under physician supervision, they support the complete entry of data onto e-CRFs. They have no authority to change data; the investigator undertakes this.

May the sponsor interfere with the service? Only through the financing agreement, basic GCP training and study-specific trainings. Involvement beyond training is prohibited by the guideline; trainings must also be communicated to the contract research organisation in advance.

When is the assignment notified, and when does the person start? After the TİTCK authorisation letter has been obtained for the clinical trial, the contract research organisation notifies TİTCK and the ethics committee (simultaneously); the person starts duty as of the date of the TİTCK notification. The ethics committee or TİTCK may cancel the assignment with justification.

Source: Klinik Araştırmalarda Merkez Organizasyon Yönetimi Esaslarına İlişkin Kılavuz (Guideline on the Principles of Site Organisation Management in Clinical Trials), 13 November 2015, TİTCK. Full text: our legislation library. The guideline's previous version, put into effect by Approval No. 95052 dated 06.08.2014, has been repealed.